Best, Netherlands
Philips Medical Systems Nederlands recalls
8 recalls recorded since 2018, most recently on 25 March 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls8
Ongoing (FDA)0
Terminated or completed8
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 25 March 2019
- Terminated
- 4 June 2020
- Reason
- Magnet Energization Device (MED) can have a residual voltage on output terminal, may cause electrical shocks to personnel servicing the MED, MDD or connected cabling.
- Distribution
- US Distribution to state of: FL and Internationally to: Switzerland and Germany.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1240-2019
- Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply power to charge the
Terminated Class II Medical devices
- Recall started
- 19 February 2019
- Terminated
- 14 October 2020
- Reason
- Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or continuous inability of making live fluoroscopy images or exposures.
- Distribution
- US Nationwide Distribution in the states of CA, FL, MI, OR, PA, TX and WA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1140-2019, Z-1141-2019
- Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and
- Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD10 F 722003 Allura Xper FD10 722005 Allura Xper FD10/10 722006 Allura Xper FD20 722008 Allura Xper FD20 Biplane 722
Terminated Class II Medical devices
- Recall started
- 21 December 2018
- Terminated
- 19 November 2020
- Reason
- There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
- Distribution
- U.S. Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0884-2019, Z-0903-2019, Z-0890-2019, Z-0882-2019, Z-0900-2019, Z-0876-2019, Z-0923-2019, Z-0911-2019, Z-0926-2019, Z-0909-2019, Z-0888-2019, Z-0907-2019 and 52 more
- Achieva XR 1.5T/3.0T, Model Number 781153. Nuclear Magnetic Resonance Imaging System
- SmartPath to dStream for XR and 3.0T, Model Number 781270. Nuclear Magnetic Resonance Imaging System
- Intera 1.5T Achieva CV Nova, Model Number 781174. Nuclear Magnetic Resonance Imaging System
- Enterprise 1.5T, Model Number 781145. Nuclear Magnetic Resonance Imaging System
- SmartPath to dStream for 1.5T, Model Number 781260. Nuclear Magnetic Resonance Imaging System
- Intera 1.0T Power/Pulsar, Model Number 781103. Nuclear Magnetic Resonance Imaging System
- Ingenia Elition X, Model Number 781358. Nuclear Magnetic Resonance Imaging System
- Ingenia 3.0T, Model Number 781342. Nuclear Magnetic Resonance Imaging System
- and 56 more product lines
Terminated Class II Medical devices
- Recall started
- 3 December 2018
- Terminated
- 12 May 2020
- Reason
- During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement.
- Distribution
- CA, MN, NJ, NY, OH, TN, TX. Foreign distribution to Canada, Belgium, France, Germany, INdia, Japna, Netherlands, South Africa, Sweden, Switzerland, UAE.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0694-2019
- Ingenia Elition S, Ingenia Elition X
Terminated Class II Medical devices
- Recall started
- 30 November 2018
- Terminated
- 27 March 2024
- Reason
- Philips has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1). When performing Cine runs, the Azurion's automatic exposure control software may set technique factors that result in radiation emissions too low to obtain useful diagnostic images.
- Distribution
- Nationwide
- Initiated
- FDA Mandated
- Recall number
- Z-1997-2019
- Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
Terminated Class II Medical devices
- Recall started
- 1 May 2018
- Terminated
- 8 June 2020
- Reason
- The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and the table will start to rotate from 0 to + 90 /- 90 degree with high speed. This rotating movement can not be stopped by the user. This could potentially lead to the patient falling off the table. There is a risk of injury for the patient, user, or bystander.
- Distribution
- US nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2300-2018, Z-2301-2018
- OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028
- OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025
Terminated Class II Medical devices
- Recall started
- 26 March 2018
- Terminated
- 12 June 2020
- Reason
- The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user.
- Distribution
- Worldwide Distribution: US (Nationwide) and countries of: Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Farce Islands, Finland, France, Germany, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Korea, Republic of, Latv
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1607-2018, Z-1604-2018, Z-1605-2018, Z-1609-2018, Z-1608-2018, Z-1606-2018, Z-1603-2018
- Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more
- 708033 URODiagnost As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human pat
- MultiDiagnost Eleva 708036 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on h
- MultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventio
- MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventio
- Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventiona
- MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on huma
Terminated Class II Medical devices
- Recall started
- 23 June 2016
- Terminated
- 8 February 2023
- Reason
- Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering.
- Distribution
- Worldwide distribution. US states of: AL, AZ, FL, GA, IL, MA, MO, NJ, OR, and VA; Netherlands, United Kingdom, Poland, Spain, France, Czech Republic, India, Brazil, Singapore, Japan, Colombia, United Arab Emirates, China, Russian Federation, Oman, and Mexico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1904-2021
- Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.
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.