Hillrom WatchCare Incontinence System recalled for radio frequency interference risk
Baxter Healthcare is recalling the Hillrom WatchCare Incontinence Management System due to radio frequency emissions that may interfere with other critical medical devices including insulin pumps and fetal monitors.
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 medical device recall. Potential radio frequency interference with critical medical devices such as insulin pumps and fetal monitors poses a significant risk of patient harm, even though no incidents have been reported to date.
Plain-English summary
The Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed (Product Code P00697905) is being recalled by Baxter Healthcare Corporation. The recall affects 814 units distributed in the United States. The device carries FDA Medical Device Listing UDI/DI 887761984998 and includes all serial numbers.
Radio frequency emissions from the WatchCare device may potentially interfere with other medical devices used in hospital settings, including telemetry devices, bladder scanners, fetal monitors and dopplers, infusion pumps, and insulin pumps. Such interference could affect the proper operation of these critical medical devices.
This is an FDA Class I recall. Refer to FDA recall number Z-0142-2023 for additional information.
The recalled product
- Product
- Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P00697905
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 814
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 887761984998
- 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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