The Recall Desk
SevereFDA (Devices)·Z-0143-2023·Announced 2022-11-09

Hillrom WatchCare Incontinence System Recalled for Radio Frequency Interference

Baxter Healthcare recalls the Hillrom WatchCare Incontinence Management System for Progressa Bed due to potential radio frequency emissions that may interfere with other medical devices including telemetry monitors and infusion 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 is an FDA Class I medical device recall, which under the rubric guidelines must never score below 4. The hazard involves potential radio frequency interference with critical life-sustaining medical devices including infusion pumps and insulin pumps.

Plain-English summary

The Hillrom Hospital Bed Accessory Watch Care Incontinence Management System for Progressa Bed (Product Code P00697903, UDI/DI 00887761998889) is being recalled by Baxter Healthcare Corporation. A total of 1,137 units are affected by this recall.

The device may emit radio frequency that could potentially interfere with the operation of other medical equipment in the hospital environment. Devices that could be affected include telemetry devices, bladder scanners, fetal monitors/dopplers, infusion pumps, and insulin pumps.

This recall affects healthcare facilities in the United States that use this incontinence management system with Progressa Beds. Healthcare providers should immediately remove affected units from service and contact Baxter Healthcare Corporation for further instructions regarding replacement or corrective measures.

The recalled product

Product
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P00697903.
Manufacturer
Baxter Healthcare Corporation
Hazard
  • electromagnetic-interference
  • 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 00887761998889
  • all serial numbers

Distribution

Distribution scope not specified by the agency.