Z-0144-2023 Class I Ongoing
FDA device recall Z-0144-2023 was initiated by Baxter Healthcare Corporation on September 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 pum… The recall status is ongoing. Affected quantity: 63 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 9, 2022
- Initiation Date
- September 30, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 63 units
Product Description
Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code/Part Number P00697902
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 887761998872, all serial numbers