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Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the WatchCare Incontinence Management System due to potential for radio frequency (RF) interference with other medical devices. The WatchCare system is designed to discreetly alert the caregiver of an incontinence event. Although the WatchCare system has been developed to comply with the most recent RF standards, it radiates RF that might affect other devices in the vicinity, including devices on both patients and staff members. This RF interference could result in erroneous readings or additional malfunctions of these other devices and could therefore result in inappropriate medical intervention. Depending on the intended use of the device that malfunctions, there may be different hazardous situations that could occur. This product is manufactured by Hillrom, which was acquired by Baxter in late 2021.
Baxter is also issuing an updated customer notification letter for this correction, replacing the previous letter issued on September 30, 2022.
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