FDA-Device2022-03-09Class I
Philips Respironics V60 Plus Ventilator Part Number 1138747
Respironics California, LLC
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).
Sold states
U.S.: AR, CA, FL, GA, IN, LA, MD, MO, NY, PA, SC, TN and TX. O.U.S. N/A
Affected count
294 systems
Manufactured in
2271 Cosmos Ct, Carlsbad, CA, United States
Products
Philips Respironics V60 Plus Ventilator Part Number 1138747
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0663-2022Don't want to check this manually?
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