Baxter Healthcare Corporation is recalling 1,135 Life2000 Ventilation Systems sold under the Welch Allyn and Breathe Technologies brands. The ventilation system's battery charger can fail, which triggers an audible and visual alarm and causes the ventilator to become completely inoperable. No injuries or incidents have been reported to date. This recall affects models BT-20-0002, BT-20-0002A, and BT-20-0002AP, which are used by patients to assist with breathing in home healthcare settings.
If the battery charger fails while a patient is relying on the ventilator for breathing support, the device will stop working. This sudden loss of ventilation poses a critical risk to the patient's health and safety.
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Sources: FDA iRES · Raw API Response
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