Hillrom WatchCare Incontinence System Recalled for Radio Frequency Interference
Baxter Healthcare recalls the Hillrom WatchCare Incontinence Management System (63 units in US) because radio frequency emissions from the device may interfere with other medical equipment including infusion pumps 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: FDA Class I classification requires minimum score of 4 per rubric. The potential for radio frequency interference with critical medical devices (infusion pumps, insulin pumps, fetal monitors, telemetry) in a hospital setting poses serious risk, even though no illnesses or injuries have been reported to date.
Plain-English summary
Baxter Healthcare Corporation is recalling the Hillrom Hospital Bed Accessory (WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code P00697902). The recall involves 63 units distributed in the United States.
The device emits radio frequency energy that may interfere with other medical equipment in use near the bed. Affected devices can include telemetry monitors, bladder scanners, fetal monitors or dopplers, infusion pumps, and insulin pumps—equipment critical to patient monitoring and treatment.
This recall affects hospitals and healthcare facilities using the WatchCare system with the VersaCare bed. The recalled units are identified by UDI/DI 887761998872 with all serial numbers included in the recall.
Healthcare providers should immediately discontinue use of affected units and contact Baxter Healthcare Corporation for further guidance and replacement options. Verify your equipment against the recall identification information to determine if your facility is affected.
The recalled product
- Product
- Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code/Part Number P00697902
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 63
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 887761998872
- 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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