The Recall Desk
SevereFDA (Devices)·Z-0144-2023·Announced 2022-11-09

Hillrom WatchCare Incontinence System Recalled for Radio Frequency Interference

Baxter Healthcare recalls the Hillrom WatchCare Incontinence Management System (63 units in US) because radio frequency emissions from the device may interfere with other medical equipment including infusion pumps 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: FDA Class I classification requires minimum score of 4 per rubric. The potential for radio frequency interference with critical medical devices (infusion pumps, insulin pumps, fetal monitors, telemetry) in a hospital setting poses serious risk, even though no illnesses or injuries have been reported to date.

Plain-English summary

Baxter Healthcare Corporation is recalling the Hillrom Hospital Bed Accessory (WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code P00697902). The recall involves 63 units distributed in the United States.

The device emits radio frequency energy that may interfere with other medical equipment in use near the bed. Affected devices can include telemetry monitors, bladder scanners, fetal monitors or dopplers, infusion pumps, and insulin pumps—equipment critical to patient monitoring and treatment.

This recall affects hospitals and healthcare facilities using the WatchCare system with the VersaCare bed. The recalled units are identified by UDI/DI 887761998872 with all serial numbers included in the recall.

Healthcare providers should immediately discontinue use of affected units and contact Baxter Healthcare Corporation for further guidance and replacement options. Verify your equipment against the recall identification information to determine if your facility is affected.

The recalled product

Product
Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code/Part Number P00697902
Manufacturer
Baxter Healthcare Corporation
Hazard
  • rf-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 887761998872
  • all serial numbers

Distribution

Distribution scope not specified by the agency.