Recall Z-1558-2025 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Baxter Healthcare Corporation
Welch Allyn Connex Vital Signs Monitor (CVSM):
| Date | Apr 14, 2025 (initiated Mar 24, 2025) |
| Status | Open, Classified |
| Reason | There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter. |
| Root cause | Process design |
| Action | An URGENT MEDICAL DEVICE CORRECTION notification letter dated 3/24/25 was sent to customers. Actions to be Taken by Customers 1. DO NOT USE UNAPPROVED BATTERIES. Baxter asks customers to only use the approved Baxter / Welch Allyn BATT99 battery, consistent with product labeling due to their safety and performance testing. 2. INSPECT ALL DEVICES. If you have a device identified in the affected product table above, check the device for the correct battery type. See Figure 1 below for examples of labels from approved batteries labelled with the BATT99 product code, Welch Allyn , and the Skaneat |
| Quantity | 228,412 units |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor Welch Allyn, Inc., Jun 30, 2017 |