Recall Z-1012-2022 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Draegar Medical Systems, Inc.
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
| Date | Mar 4, 2022 |
| Status | Open, Classified |
| Reason | Software issue resulting in temporary loss of central monitoring functionality. |
| Root cause | Software design |
| Action | A notification signed 03/08/2022, issued via certified mail on 03/11/2022 and 03/24/2022, notified customers of the impacted software versions, that a software update will be deployed to correct the issue, and provided interim instructions regarding use of USB devices. Customers are to notify all users and return the acknowledgement form. For questions please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349). |
| Quantity | 1950 (1574 OUS + 376 US) |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130711 | INFINITY CENTRALSTATION WITH INFINITY M300 Draeger Medical Systems, Inc., Apr 11, 2013 |