Andover, MA, United States
Draegar Medical Systems, Inc. recalls
8 recalls recorded since 2018, most recently on 4 March 2022. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls8
Ongoing (FDA)5
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 4 March 2022
- Reason
- Software issue resulting in temporary loss of central monitoring functionality.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, IA, ID, IL, IN, LA, MN, MS, NC, NE, NH, NY, OH, PA, SD, TN, TX, WA, WI, and 58 additional foreign countries.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1012-2022
- Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
Ongoing Class II Medical devices
- Recall started
- 23 December 2020
- Reason
- The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and read the header data of files in the memory of the device. Under this situation, the device will try to reboot to mitigate the error. The device will be available again for use within 30 seconds. If this error continues and the M540 reboots three times in a time span of 10 minutes, it will enter a fail-state. A fail-state will annunciate itself with a continuous sound to alert the user. The M540 will reset to factory default and the user can manually configure and readmit the patient to continue patient monitoring.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WY and the countries of Argentina, Australia, Austria, Bahrain, Belgium,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1104-2021
- Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by
Ongoing Class II Medical devices
- Recall started
- 9 October 2019
- Reason
- The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering.
- Distribution
- US nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0372-2020
- Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301
Ongoing Class II Medical devices
- Recall started
- 13 September 2019
- Reason
- Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0258-2020
- The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.
Ongoing Class II Medical devices
- Recall started
- 8 February 2019
- Reason
- The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication.
- Distribution
- US Nationwide distribution including Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0974-2019, Z-0975-2019
- Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Outpu
- Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is
Terminated Class II Medical devices
- Recall started
- 28 March 2018
- Terminated
- 21 April 2020
- Reason
- Software anomaly resulting in the loss of patient settings and stored patient data.
- Distribution
- Worldwide Distribution - USA (nationwide) and to the countries of : Angola, Argentina, Australia Austria Azerbaijan Bahrain Belgium Bolivia Brazil Brunei Dar-es-S Canada Chile China Colombia Costa Rica Czech Republic Denmark Egypt Finland France Germany Ghana Greece Hong Kong H
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1813-2018
- Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049
Terminated Class II Medical devices
- Recall started
- 21 February 2018
- Terminated
- 20 April 2020
- Reason
- The invasive pressure visual and audible alarms may not activate.
- Distribution
- Worldwide Distribution - USA (nationwide) and the following countries:Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Botswana, Brazil, Brunei Dar-es-S, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, Egypt, Finland, France, Germany, Gre
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1382-2018
- Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 40
Terminated Class II Medical devices
- Recall started
- 4 October 2017
- Terminated
- 15 June 2018
- Reason
- Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Dr¿ger Infinity Acute Care System, may permit liquid ingress inconsistent with their IPX4 rating, which could potentially result in an incorrect measured value of invasive blood pressure.
- Distribution
- Nationally
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0942-2018
- INFINITY DUAL HEMO MCable Pod
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.