Recall Z-0144-2023 ยท KPN Alarm, Conditioned Response Enuresis
Baxter Healthcare Corporation
Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code/Part Number P00697902
| Date | Oct 31, 2022 (initiated Sep 30, 2022) |
| Status | Open, Classified |
| Reason | Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps). |
| Root cause | Device Design |
| Action | Baxter issued an Urgent Medical Device Correction on 09/30/2022. An updated letter was sent on 10/21/2022 to request that users temporarily stop using the WatchCare system. Hillrom, a Baxter company, has received reports of Radio Frequency (RF) interference with other devices near beds that are installed with WatchCare. Specifically, RF interference has been reported with telemetry devices, a bladder scanner, a fetal monitor/doppler, an infusion pump, and a personal use insulin pump. Other third-party medical devices may also be affected. While the system was developed to comply with the most- |
| Quantity | 63 units |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.