Recall Z-0141-2023— Baxter Healthcare Corporation

Class I · Ongoing

Class I FDA medical device recall by Baxter Healthcare Corporation, initiated 2022-09-30. FDA's recall record names no specific 510(k) clearance for this event. 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, 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: 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)..

Recalling firm
Baxter Healthcare Corporation
Classification
Class I
Status
Ongoing
Initiated
2022-09-30
Firm location
Deerfield, IL, United States

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.