FDA Warns – Class I Recall Issued for Baxter Hillrom WatchCare IMS

Baxter Hillrom is recalling their Incontinence Management System after reports that the radiofrequency emissions form the device could interfere with other vital medical equipment.

The WatchCare Incontinence Management System (IMS) is designed to detect moisture through Centrella, Progressa, and VersaCare hospital beds and disposable incontinence pads, and immediately notify the caregiver.

Recall Information

  • Product Name: WatchCare Incontinence Management System (IMS)
  • Product Models:
    • P7900B Centrella Bed with WatchCare
    • P00697901: Hospital Bed Accessory, WatchCare System for VersaCare Bed Rev. A-J
    • P00697902: Hospital Bed Accessory, WatchCare System for VersaCare Bed Rev. K
    • P00697903: Hospital Bed Accessory, WatchCare System for Progressa Bed
    • P00697905: Hospital Bed Accessory WatchCare System for Centrella Bed
  • Distribution Dates: August 1, 2018 to September 1, 2022
  • Devices Recalled in the U.S.: 8,550
  • Date Initiated by Firm: September 30, 2022

Baxter Hillrom received 96 complaints suggesting RF frequencies from the IMS devices could interfere with the efficacy of more critical equipment in the room such as:

  • Infusion pumps
  • Insulin pumps
  • Blood glucose sensors
  • Fetal monitors / dopplers
  • Telemetry devices
  • Bladder scanners

All of the interferences reported occurred with other devices less than 1 meter from the IMS. Fortunately, no serious injuries or deaths have been reported as a result of the interference.

Baxter Hillrom released an Urgent Medical Device Correction Letter recommending actions for clinicians, biomedical engineers, and other end users to take in the immediate time following the recall.

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