Hillrom WatchCare Incontinence System Recalled for Radio Frequency Emissions
Baxter Healthcare is recalling 129 units of the Hillrom WatchCare incontinence management system due to radio frequency emissions that may interfere with other hospital medical devices such as telemetry units, fetal monitors, and insulin pumps.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall carries a Class I designation from the FDA, which mandates a minimum severity score of 4. Although no illnesses or injuries have been reported, the potential for radio frequency emissions to interfere with critical medical devices such as telemetry and insulin pumps in a hospital setting constitutes a serious patient safety risk.
Plain-English summary
The Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System (Product Code P00697901) for VersaCare Bed is being recalled by Baxter Healthcare Corporation. The recall affects 129 units distributed in the United States.
The reason for the recall is that radio frequency emissions from a functioning WatchCare device may potentially interfere with other medical devices commonly used in hospital settings. These devices include telemetry devices, bladder scanners, fetal monitors/dopplers, infusion pumps, and insulin pumps.
Healthcare facilities using this incontinence management system should be aware that the device's RF emissions could disrupt critical monitoring and therapeutic equipment. Facilities should contact Baxter Healthcare Corporation for guidance on the recall and available alternatives or replacement procedures.
The recalled product
- Product
- Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product Code/Part Number P00697901
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 129
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 00887761998865
- all serial numbers
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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