Recall Z-2581-2023 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Baxter Healthcare Corporation
Welch Allyn Connex Spot Monitor
| Date | Sep 12, 2023 (initiated Aug 10, 2023) |
| Status | Open, Classified |
| Reason | Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display. |
| Root cause | Device Design |
| Action | The consignee recall notification was sent out via email 08/10/2023. The letter instructs the consignee to immediately locate, isolate, and cease all use of the affected product, contact Baxter Customer Service and Technical Support to arrange for return and replacement of the impacted units, acknowledge receipt by responding on the customer portal, and notify other affected customers of the consignee. Affected product will be removed from the field and customers will receive replacement units of the Connex Spot Monitor. Impacted product will be returned to Baxter and will be destroyed per the |
| Quantity | 2 units |
| Distribution | US Nationwide distribution in the state of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142356 | Connex Spot Monitor,901058 Vital Signs Monitor Core Welch Allyn, Inc., Dec 19, 2014 |