Product Safety Recalls

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Respironics California, LLC Recall 89490

Description: Philips Respironics V60 Plus Ventilator Part Number 1138747

Respironics California, LLC Recall 89490 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0663-2022
Event ID89490
Event DescriptionPhilips Respironics V60 Plus Ventilator Part Number 1138747
Product TypeDevices
DistributionU.S.: AR, CA, FL, GA, IN, LA, MD, MO, NY, PA, SC, TN and TX. O.U.S. N/A
Quantity294 systems
Recall ReasonA 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).
Device Classification20220309
Device Code InfoThe Component of the Ventilators that is impacted is: N 1034132 BRACKET, CAPACITOR,MOTOR DRIVER PCB Model V60 Part Number: 1138747 Serial Numbers/UDI Code: MX0016240/ (01)00884838090996(21)MX0016240 MX0016241/ (01)00884838090996(21)MX0016241 MX0016242/ (01)00884838090996(21)MX0016242 MX0016243/ (01)00884838090996(21)MX0016243 MX0016244/ (01)00884838090996(21)MX0016244 MX0016245/ (01)00884838090996(21)MX0016245 MX0016246/ (01)00884838090996(21)MX0016246 MX0016247/ (01)00884838090996(21)MX0016247 MX0016248/ (01)00884838090996(21)MX0016248 MX0016522/ (01)00884838090996(21)MX0016522 MX0016523/ (01)00884838090996(21)MX0016523 MX0016525/ (01)00884838090996(21)MX0016525 MX0016527/ (01)00884838090996(21)MX0016527 MX0016529/ (01)00884838090996(21)MX0016529 MX0016531/ (01)00884838090996(21)MX0016531 MX0016532/ (01)00884838090996(21)MX0016532 MX0016533/ (01)00884838090996(21)MX0016533 MX0016534/ (01)00884838090996(21)MX0016534 MX0016535/ (01)00884838090996(21)MX0016535 MX0016536/ 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Center Classification Date20220225
Recall Initiation Date20220124
Recalling FirmRespironics California, LLC
Initial Notification Letter
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