November 29, 2022

FDA: Class I recall of Baxter Hillrom WatchCare IMS for RF interference risk

By: Judy Mathias
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Editor's Note

The Food and Drug Administration, on November 23, identified the recall by Baxter Hillrom of its WatchCare Incontinence Management System (IMS) as Class I, the most serious.

The recall was initiated because of the risk for radiofrequency (RF) emissions from WatchCare devices that may interfere with other devices, including equipment that is critical to the health of patients, such as infusion pumps and telemetry devices.

To date, there have been 96 complaints of RF interference and no reports of serious injuries or deaths. RF interference occurred at distances less than 1 meter in all but two cases.

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