Z-0141-2023 Class I Ongoing
FDA device recall Z-0141-2023 was initiated by Baxter Healthcare Corporation on Sep 30, 2022 and is designated Class I. Reason for recall: Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion… The recall status is ongoing. Affected quantity: 6407 units.
Recall details
- Product Type
- Devices
- Report Date
- Nov 9, 2022
- Initiation Date
- Sep 30, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6407 units
Product description
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, P7900B100292, P7900B100296, P7900B100302, P7900B100303, P7900B100304, P7900B100305, P7900B100312, P7900B100316, P7900B100318, P7900B100335, P7900B100341, P7900B100342, P7900B100354, P7900B100361, P7900B100368, P7900B100372, P7900B100381, P7900B100382, P7900B100384, P7900B100385, P7900B100387, P7900B100388, P7900B100392, P7900B100395, P7900B100396, P7900B100407, P7900B100408, P7900B100438, P7900B100441, P7900B1PL270, P7900B1PLT71, P7900B1SPL05, P7900B200193, P7900B200195, P7900B200230, P7900B200236, P7900B200264, P7900B200268, P7900B200292, P7900B200302, P7900B200318, P7900B200342, P7900B200361, P7900B200372, P7900B200381, P7900B200382, P7900B200392, P7900B200395, P7900B200396, P7900B200408, P7900B200439, P7900B200441, P7900B200443, P7900B200445, P7900B200452, P7900B200453, P7900B200464, P7900B200485, P7900B2SPL12, P7900B300441, P7900B300453, P7900B300518
Reason for recall
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).
Distribution pattern
US
Code information
UDI/DI 887761985162, all serial numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0141-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026