Murrysville, PA, United States
Philips Respironics, Inc. recalls
26 recalls recorded since 2018, most recently on 2 March 2026. 24 are listed as ongoing. Status and classification are as published by the FDA.
Recalls26
Ongoing (FDA)24
Terminated or completed2
Class I (FDA)21
Ongoing Class I Medical devices
- Recall started
- 2 March 2026
- Reason
- Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
- Distribution
- Worldwide distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Austria, Australia, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bolivia, Brazil, Bahamas, Canada, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1617-2026, Z-1616-2026, Z-1615-2026, Z-1614-2026
- Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
- Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
- Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
- Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
Ongoing Class I Medical devices
- Recall started
- 2 March 2026
- Reason
- In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
- Distribution
- Worldwide Distribution. US Nationwide, Argentina, Austria, Australia, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bolivia, Brazil, Bahamas, Canada, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Georgia, Fr
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1647-2026, Z-1649-2026, Z-1648-2026, Z-1646-2026
- Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
- Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
- Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
- Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
Ongoing Class II Medical devices
- Recall started
- 7 October 2025
- Reason
- Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.
- Distribution
- US Nationwide distribution in the states of GA, ID, KY, NJ, NY and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0481-2026
- SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113600
Ongoing Class I Medical devices
- Recall started
- 30 June 2025
- Reason
- Devices may possess a programming error resulting in an incorrect device configuration.
- Distribution
- Worldwide - US Nationwide in the states of AL, CA, CO, FL, GA, IN, LA, MD, NE, NJ, NY, PA, TX & DC. The country of France.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2228-2025, Z-2229-2025, Z-2227-2025
- DreamStation Auto BiPAP. Non-Continuous Ventilator.
- DreamStation Auto. Non-Continuous Ventilator.
- DreamStation Auto CPAP. Non-Continuous Ventilator.
Ongoing Class I Medical devices
- Recall started
- 9 May 2025
- Reason
- This device does not indicate for use in patients with respiratory failure.
- Distribution
- Worldwide distribution: US (Nationwide)including Guam and Puerto Rico; OUS (Foreign) to countries of: United Arab Emirates (AE), Argentina (AR), Austria (AT), Australia (AU), Bosnia and Herzegovina (BA), Belgium (BE), Brazil (BR), Canada (CA), Chile (CL), China (CN), Colombia (CO), Costa Rica (CR),
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2037-2025, Z-2035-2025, Z-2036-2025
- BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS
- BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
- BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the
Ongoing Class I Medical devices
- Recall started
- 7 October 2024
- Reason
- Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
- Distribution
- Worldwide distribution - US Nationwide and the countries of AE, AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GF, GI, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JE, JO, JP, KE, KR, KW, LB, LT, LY, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0292-2025, Z-0293-2025, Z-0294-2025, Z-0295-2025, Z-0296-2025, Z-0290-2025, Z-0291-2025
- Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transp
- Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B, FR2200X14B, FX2200X15B, EU2200X15B, IA2200X15B, IT2200X21B, KR2200X15B, TR2200X15B
- Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
- Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
- LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
- Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN2100X19, EU2100X19.
- Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110X15B, BL2110X15B, EU2110X15B, BR2110X18B, LA2110X15B, EE2110X15B, FR2110X14B, GB2110X15B, ND2110X15B
Ongoing Class I Medical devices
- Recall started
- 16 July 2024
- Reason
- Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
- Distribution
- Worldwide distribution: US (nationwide) and OUS (foreign) countries of: AU, BD, BE, BG, BO, BR, BS, CH, CL, NL, CN, CO, CZ, DE, DK, FR, SE, GB, GF, GR, GT, HK, HR, HU, IE, IL, IN, IT, JP, KE, KW, LB, LT, MA, ME, MA, MT, MQ, MX, NO, NP, OM, PA, PE, PF, PK, PL, PT, PY, QA, RE, RO, RS, RU, SA, SE, SI,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2944-2024, Z-2943-2024, Z-2942-2024
- Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada DE2100X13B Trilogy Evo O2, Germany DE2
- Trilogy Evo Universal Ventilator, Model No. DS2000X11B
- Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, German
Ongoing Class I Medical devices
- Recall started
- 1 April 2024
- Reason
- Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death.
- Distribution
- US Nationwide distribution and OUS International distribution to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1817-2024
- OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
Ongoing Class I Medical devices
- Recall started
- 26 March 2024
- Reason
- Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
- Distribution
- Worldwide distribution. US Nationwide including PR and GU; Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, and Turkey.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1812-2024, Z-1813-2024, Z-1814-2024
- BiPAP V30 Auto Ventilator, Part Number 1111178
- BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R1111169 R1111177 R11161
- BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1111
Ongoing Class I Medical devices
- Recall started
- 19 March 2024
- Reason
- Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
- Distribution
- Domestic: Nationwide Distribution; Foreign: AE, AR, AT, AU, BD, BE, BG, BO, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GF, GI, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JE, JO, JP, KE, KR, KW, LB, LT, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PF,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1505-2024, Z-1501-2024, Z-1499-2024, Z-1503-2024, Z-1502-2024, Z-1500-2024, Z-1504-2024
- Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
- LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
- Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
- Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
- Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
- Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
- Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Ongoing Class II Medical devices
- Recall started
- 27 November 2023
- Reason
- The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for patients less than 10 kg. Potential harms if devices are used on contraindicated patients include barotrauma, hypoventilation/hypercapnia, and rebreathing of excessive CO2.
- Distribution
- Worldwide distribution: US (nationwide)-AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Including PR; and OUS (International) including countries of: AE, AR
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0638-2024
- Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B EE2110X15B ES2100X15B ES2110X15B EU2100X15B EU2100X19 EU2110X15B FR21
Ongoing Class I Medical devices
- Recall started
- 25 August 2023
- Reason
- Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
- Distribution
- US Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2631-2023
- Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
Ongoing Class II Medical devices
- Recall started
- 25 May 2023
- Reason
- There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".
- Distribution
- Foreign Distribution: Korea.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2106-2023
- Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
Ongoing Class I Medical devices
- Recall started
- 1 May 2023
- Reason
- Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.
- Distribution
- US Nationwide. Global Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1651-2023, Z-1649-2023, Z-1652-2023, Z-1650-2023
- Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B
- Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2110X21B, ES2110X15B,
- Trilogy Evo Universal Ventilator, Model Number DS2000X11B
- Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, EU2100X15B, EU2100X19, EE2100X
Ongoing Class I Medical devices
- Recall started
- 1 March 2023
- Reason
- The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.
- Distribution
- Worldwide distribution. US Nationwide including Puerto Rico, and countries of AE, AR, AT, AU, BD, BE, BG, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GE, GT, HK, HR, HU, ID, IL, IE, IN, IT, JP, KW, LB, LT, MM, MQ, MX, MY, NG, NL, NO, NP, NZ, PE, PF, PH, PK, PL, PT, QA, RO,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1288-2023, Z-1289-2023, Z-1287-2023
- Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B, KR2200X15B, IA2200X15B, FR2200X14B, ND2200X15B, IT2200X21B, ES2200X15B, DE2200X13B, BL2200
- Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B
- Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR2100X15B, IA2100X15B, P
Ongoing Class I Medical devices
- Recall started
- 10 February 2023
- Reason
- A limited number of remediated Philips DreamStation units may experience communication issues when connecting to the cloud-based care management application. Should this be the case, this may affect the ability to download prescription settings to the device or the device may have incorrect prescription settings for the patient.
- Distribution
- US Nationwide. France, Reunion.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1322-2023
- Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14. Used to deliver positive airway pressure therapy for the treatment of Obstructive Sleep
Ongoing Class I Medical devices
- Recall started
- 7 December 2022
- Reason
- The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.
- Distribution
- US Nationwide and Global Distribution to countries of: Australia, Brazil, Canada, China, Germany, Japan, Korea, and Latin America.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0882-2023, Z-0883-2023, Z-0884-2023
- Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260, CA1054096, R1054260B, R1054655TPV, AU1054096, AU1054096B, 1054096B, 10
- Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804B, R1032804TPV, 1032804B
- Philips Garbin Ventilator, Model Number 1058180B
Ongoing Class I Medical devices
- Recall started
- 6 September 2022
- Reason
- No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1783-2022, Z-1782-2022, Z-1780-2022, Z-1784-2022, Z-1781-2022
- Wisp and Wisp Youth Nasal Mask
- DreamWisp Nasal Mask with Over the Nose Cushion
- Philips Respironics Amara View Minimal Contact Full-Face Mask
- Therapy Mask 3100 NC/SP
- Philips Respironics DreamWear Full Face Mask
Ongoing Class I Medical devices
- Recall started
- 26 August 2022
- Reason
- Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
- Distribution
- Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, VA, VT, WA, WI, WV, & WY. Foreign: Australia, Austria, Bangladesh, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Hungary, In
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1654-2022, Z-1656-2022, Z-1658-2022, Z-1659-2022, Z-1655-2022, Z-1657-2022
- Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
- Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
- Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
- Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
- Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
- Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Ongoing Class I Medical devices
- Recall started
- 22 December 2021
- Reason
- Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may off-gas certain chemicals during initial use of the device.
- Distribution
- Worldwide Distribution: Distributed to the following US states: AR, CO, FL, IA, IL, KY, LA, MI, MT, OH, PA, TN, TX, UT, VA, WV, and WY; and Distributed to the following foreign countries: Argentina, Brazil, Romania, and Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0493-2022, Z-0494-2022
- Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ven
- Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mec
Ongoing Class II Medical devices
- Recall started
- 26 July 2021
- Reason
- Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).
- Distribution
- Worldwide distribution - US nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2290-2021, Z-2288-2021, Z-2289-2021, Z-2287-2021
- Trilogy Evo Universal, Product number DS2000X11B
- Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X2
- Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
- Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, L
Ongoing Class I Medical devices
- Recall started
- 14 June 2021
- Reason
- The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
- Distribution
- Worldwide distribution including US Nationwide, Argentina, Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Korea, and Latin America.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1956-2021, Z-1958-2021, Z-1957-2021
- Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
- A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
- A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use
Ongoing Class I Medical devices
- Recall started
- 14 June 2021
- Reason
- The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
- Distribution
- Global distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1972-2021, Z-1974-2021, Z-1973-2021
- Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19 The Philips Respironics E30 ventilator is intended to pro
- SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory
- DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting The Philips Respironics E30 ventilator is intended to provid
Terminated Class II Medical devices
- Recall started
- 6 April 2021
- Terminated
- 17 January 2024
- Reason
- Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.
- Distribution
- Distribution US nationwide to states of: LA, PA, WI, CO, WV, WA, CA, TX, MO, OK, FL, and TN. Brazil, China, and Japan
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1627-2021, Z-1629-2021, Z-1628-2021, Z-1630-2021, Z-1626-2021, Z-1625-2021
- BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177
- BiPAP A30, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111143
- BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: 1111177
- BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111169
- BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169
- BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178
Terminated Class I Medical devices
- Recall started
- 19 November 2019
- Terminated
- 31 March 2021
- Reason
- Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.
- Distribution
- US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0948-2020, Z-0949-2020, Z-0945-2020, Z-0943-2020, Z-0946-2020, Z-0954-2020, Z-0950-2020, Z-0953-2020, Z-0944-2020, Z-0952-2020, Z-0947-2020, Z-0942-2020 and 1 more
- Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2,
- Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2,
- Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and
- Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2,
- Garbin EVO Ventilator, Linde - Model Number: LD2110X23B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, an
- LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and
- Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2,
- Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2,
- and 5 more product lines
Ongoing Class I Medical devices
- Recall started
- 12 June 2018
- Reason
- In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based polyurethane (PE-PUR) foam may degrade into particles. This 2018 correction has been superseded by the device removal and rework described in Philips Respironics 2021 recall action for the same devices.
- Distribution
- Global Distribution. US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0785-2022
- Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.