The FDA issued a notice declaring the Baxter (NYSE:BAX) WatchCare incontinence management system (IMS) recall as Class I, the most serious kind.
Baxter last month issued an urgent medical device correction for the WatchCare IMS. The system appears to radiate radiofrequency (RF) that may affect other devices on caregivers and patients. The list of potentially affected devices includes infusion/insulin pumps, blood glucose sensors, fetal monitors/dopplers, telemetry devices and bladder scanners.
Other third-party medical devices may be affected, too, according to the FDA notice. RF interference could cause erroneous readings or malfunctions of the devices on both patients and staff.
Baxter reported 96 complaints of RF interference. To date, all cases but two experienced interference at a distance less than one meter. The company said it has insufficient data on distance for the two remaining reported interferences. It received no reports of serious injuries or deaths related to the issue.
The company distributed the affected products between Aug. 1, 2018, and Sept. 1, 2022. To date, it recalled 8,550 devices in the U.S. since initiating the recall on Sept. 30, 2022.
WatchCare IMS includes specific Centrella, Progressa, and VersaCare hospital beds and disposable incontinence pads. It discreetly alerts the caregiver of an incontinence event. Its usual uses include critical care and medical/surgical settings, as well as in other clinical areas.
The affected product models include:
- P7900B Centrella Bed with WatchCare
- P00697901: Hospital Bed Accessory, WatchCare System for VersaCare Bed Rev. A-J
- P00697902: Hospital Bed Accessory, WatchCare System for VersaCare Bed Rev. K
- P00697903: Hospital Bed Accessory, WatchCare System for Progressa Bed
- P00697905: Hospital Bed Accessory WatchCare System for Centrella Bed