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Recall Observatory FDA recall evidence

Device product

Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code/Part Number P00697902

Z-0144-2023

September 30, 2022

Class I

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 90865
Status
Ongoing
Classification
Class I
Quantity
63 units
Official record key
device-enforcement:Z-0144-2023

Official wording

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).

Code information: UDI/DI 887761998872, all serial numbers

Distribution pattern: US

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).