Hillrom Centrella Hospital Bed Radio Frequency Emissions May Interfere with Medical Devices
Hillrom Centrella Hospital Beds with WatchCare systems may emit radio frequency signals that interfere with other medical devices. Approximately 6,407 units are affected and distributed in the US.
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 FDA Class I recall meets the threshold for Severe classification. Potential interference with critical medical devices such as infusion pumps and insulin pumps poses a direct patient safety risk in healthcare settings.
Plain-English summary
Baxter Healthcare Corporation is recalling the Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System. The recall is due to potential radio frequency emissions from the WatchCare device.
Radio frequency emissions from a functioning WatchCare device may impact other medical devices, including telemetry devices, bladder scanners, fetal monitors, doppler devices, infusion pumps, and insulin pumps.
The recall affects approximately 6,407 units distributed in the United States. Healthcare facilities using the affected equipment should contact Baxter Healthcare Corporation for guidance regarding this recall.
The recalled product
- Product
- Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System, Product code/Part numbers: P7900B100193, P7900B100195, P7900B100230, P7900B100236, P7900B100239, P7900B100244, P7900B100256, P7900B100257, P7900B100259, P7900B100264, P7900B100268, P7900B100269…
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Hospital Beds
- Affected units
- 6,407
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 887761985162
- 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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- High
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