Recall Z-0372-2020 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Draegar Medical Systems, Inc.
Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301
| Date | Oct 9, 2019 |
| Status | Open, Classified |
| Reason | The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering. |
| Root cause | Software design |
| Action | An Urgent Medical Device Recall notification letter dated 10/9/19 was sent to customers. Recommended cybersecurity precautions: While we are in the process of updating the software, we recommend that you follow best recommended practices to limit access to the devices and wireless network: " Physical security of the patient monitors is recommended and is the responsibility of the operating organization. " Physical security boundaries to prevent access to your facility's network infrastructure is recommended and is the responsibility of the operating organization. " Drager relies on the medi |
| Quantity | 12204 |
| Distribution | US nationwide distribution. |
| 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 |