Recall Z-2734-2017 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Draegar Medical Systems, Inc.
Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722
| Date | Jun 6, 2017 |
| Status | Terminated |
| Reason | Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station. |
| Root cause | Software design |
| Action | Draeger issued on June 6, 2017 Urgent Medical Recall letter with Addendum US serial numbers via Certified Mail addressed to Risk Manager and Director Clinical Engineering The letter instructs the consignees, if the serial number of the cockpit is on the serial number list, to remove the Cockpit from use until it can be determined whether the 4GB RAM Module is among those affected. The IACS can be used without the Cockpit and the M540 will function as the primary monitoring device once the Cockpit is disconnected. A DrgerService Representative will schedule a time to inspect the Cockpit and, i |
| Quantity | 37 US and 682 OUS |
| Distribution | AZ, NH, SD, TN, TX Foreign: Australia Austria Belgium Canada China Costa Rica France Germany Great Britian Hong Kong India Ireland Italy Japan Malaysia Namibia Netherlands Poland Portugal Russian Fed. South Africa South Korea Spain Sweden Switzerland Thailand Turkey Unit |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113798 | INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET Draeger Medical Systems, Inc., Mar 22, 2012 |