Recall Z-0258-2020 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Draegar Medical Systems, Inc.
The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.
| Date | Oct 31, 2019 (initiated Sep 13, 2019) |
| Status | Open, Classified |
| Reason | Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network. |
| Root cause | Software design |
| Action | On September 13, 2019, the firm distributed Urgent Medical Device Recall letters to customers. Customers were informed of the cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDOS) (packet storm), Spoofing, and Tampering. To mitigate the cybersecurity concerns, Draeger will be releasing software version VG4.2 for both the Cockpit and the M540, which will correct these cybersecurity vulnerabilities. The software is expected to be released for distribution in December 2019. Upgrades of the IACS systems will commence in January 2020. While the firm is in the proc |
| Quantity | 5634 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |