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Respironics California, LLC recalls Philips Respironics V60 Ventilator Part Number 1053617
Recalled March 9, 2022 · FDA recall Z-0662-2022 · Respironics California
Hazard
A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may either activate both visual and audible alarms, or it may not sound or display an alarm (a silent shutdown). · FDA Class I
Units
16 systems
Sold at
U.S.: AR, CA, FL, GA, IN, LA, MD, MO, NY, PA, SC, TN and TX. O.U.S. N/A
Description
A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may either activate both visual and audible alarms, or it may not sound or display an alarm (a silent shutdown).
Product
Philips Respironics V60 Ventilator Part Number 1053617
Manufacturer(s)
Respironics California, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →