The Recall Desk
SevereFDA (Devices)·Z-0145-2023·Announced 2022-11-09

Hillrom WatchCare Incontinence System Recalled for Radio Frequency Emissions

Baxter Healthcare is recalling 129 units of the Hillrom WatchCare incontinence management system due to radio frequency emissions that may interfere with other hospital medical devices such as telemetry units, fetal monitors, and insulin pumps.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This recall carries a Class I designation from the FDA, which mandates a minimum severity score of 4. Although no illnesses or injuries have been reported, the potential for radio frequency emissions to interfere with critical medical devices such as telemetry and insulin pumps in a hospital setting constitutes a serious patient safety risk.

Plain-English summary

The Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System (Product Code P00697901) for VersaCare Bed is being recalled by Baxter Healthcare Corporation. The recall affects 129 units distributed in the United States.

The reason for the recall is that radio frequency emissions from a functioning WatchCare device may potentially interfere with other medical devices commonly used in hospital settings. These devices include telemetry devices, bladder scanners, fetal monitors/dopplers, infusion pumps, and insulin pumps.

Healthcare facilities using this incontinence management system should be aware that the device's RF emissions could disrupt critical monitoring and therapeutic equipment. Facilities should contact Baxter Healthcare Corporation for guidance on the recall and available alternatives or replacement procedures.

The recalled product

Product
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product Code/Part Number P00697901
Manufacturer
Baxter Healthcare Corporation
Hazard
  • rf-emission
  • medical-device-interference

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 00887761998865
  • all serial numbers

Distribution

Distribution scope not specified by the agency.