Baxter Hillrom is recalling its WatchCare Incontinence Management System (IMS) following reports that the radiofrequency emissions (RF) from WatchCare devices may interfere with other medical devices. The U.S. FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.
The WatchCare Incontinence Management System (IMS) includes specific Centrella, Progressa, and VersaCare hospital beds and disposable incontinence pads. It is designed to discreetly alert the caregiver of an incontinence event. The system is usually used in critical care and medical/surgical settings as well as in other clinical areas.
Recalled 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
- (Distribution Dates: August 1, 2018 to September 1, 2022)
The company initiated the recall after receiving reports that the RF from the devices may interfere with other medical devices, including equipment that is critical to the health and wellbeing of patients, such as:
- Infusion pumps
- Insulin pumps
- Blood glucose sensors
- Fetal monitors / dopplers
- Telemetry devices
- Bladder scanners
The RF interference may cause erroneous readings or malfunctions, which could lead to inappropriate medical treatments or lack of treatment. According to the CDRH recall notice, Baxter reported 96 complaints of interference. To date, interferences in all cases but two occurred at distances less than 1 meter. There have been no reports of serious injuries or deaths related to this issue.