FDAFDA · Food and drugs·Recall number Z-0663-2022
Philips Respironics V60 Plus Ventilator Part Number 1138747
Published March 9, 2022 · Recall initiated: January 24, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Respironics California, LLC
- Distributor
- U.S.: AR, CA, FL, GA, IN, LA, MD, MO, NY, PA, SC, TN and TX. O.U.S. N/A
- Lot
- The 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/ (01)00884838090996(21)MX0016536 MX0016538/ (01)00884838090996(21)MX0016538 MX0016539/ (01)00884838090996(21)MX0016539 MX0016540/ (01)00884838090996(21)MX0016540 MX0016541/ (01)00884838090996(21)MX0016541 MX0016542/ (01)00884838090996(21)MX0016542 MX0016545/ (01)00884838090996(21)MX0016545 MX0016546/ (01)00884838090996(21)MX0016546 MX0016547/ (01)00884838090996(21)MX0016547 MX0016548/ (01)00884838090996(21)MX0016548 MX0016549/ (01)00884838090996(21)MX0016549 MX0016550/ (01)00884838090996(21)MX0016550 MX0016552/ (01)00884838090996(21)MX0016552 MX0016553/ (01)00884838090996(21)MX0016553 MX0016554/ (01)00884838090996(21)MX0016554 MX0016556/ (01)00884838090996(21)MX0016556 MX0016559/ (01)00884838090996(21)MX0016559 MX0016560/ (01)00884838090996(21)MX0016560 MX0016561/ (01)00884838090996(21)MX0016561 MX0016562/ (01)00884838090996(21)MX0016562 MX0016568/ (01)00884838090996(21)MX0016568 MX0016569/ (01)00884838090996(21)MX0016569 MX0016570/ (01)00884838090996(21)MX0016570 MX0016571/ (01)00884838090996(21)MX0016571 MX0016572/ (01)00884838090996(21)MX0016572 MX0016573/ (01)00884838090996(21)MX0016573 MX0016574/ (01)00884838090996(21)MX0016574 MX0016575/ (01)00884838090996(21)MX0016575 MX0016576/ (01)00884838090996(21)MX0016576 MX0016577/ (01)00884838090996(21)MX0016577 MX0016578/ (01)00884838090996(21)MX0016578 MX0016580/ (01)00884838090996(21)MX0016580 MX0016581/ (01)00884838090996(21)MX0016581 MX0016583/ (01)00884838090996(21)MX0016583 MX0016584/ (01)00884838090996(21)MX0016584 MX0016807/ (01)00884838090996(21)MX0016807 MX0016813/ (01)00884838090996(21)MX0016813 MX0016818/ (01)00884838090996(21)MX0016818 MX0016838/ (01)00884838090996(21)MX0016838 MX0016850/ (01)00884838090996(21)MX0016850 MX0016860/ (01)00884838090996(21)MX0016860 MX0016868/ (01)00884838090996(21)MX0016868 MX0016873/ (01)00884838090996(21)MX0016873 MX0016880/ (01)00884838090996(21)MX0016880 MX0016881/ (01)00884838090996(21)MX0016881 MX0016882/ (01)00884838090996(21)MX0016882 MX0016883/ (01)00884838090996(21)MX0016883 MX0016884/ (01)00884838090996(21)MX0016884 MX0016886/ (01)00884838090996(21)MX0016886 MX0016887/ (01)00884838090996(21)MX0016887 MX0016989/ (01)00884838090996(21)MX0016989 MX0016990/ (/01)00884838090996(21)MX0016990 MX0016991/ (01)00884838090996(21)MX0016991 MX0016992/ (01)00884838090996(21)MX0016992 MX0016993/ (01)00884838090996(21)MX0016993 MX0016994/ (01)00884838090996(21)MX0016994 MX0016995/ (01)00884838090996(21)MX0016995 MX0016996/ (01)00884838090996(21)MX0016996 MX0016997/ (01)00884838090996(21)MX0016997 MX0016998/ (01)00884838090996(21)MX0016998 MX0016999/ (01)00884838090996(21)MX0016999 MX0017000/ (01)00884838090996(21)MX0017000 MX0017001/ (01)00884838090996(21)MX0017001 MX0017003/ (01)00884838090996(21)MX0017003 MX0017004/ (01)00884838090996(21)MX0017004 MX0017005/ (01)00884838090996(21)MX0017005 MX0017006/ (01)00884838090996(21)MX0017006 MX0017007/ (01)00884838090996(21)MX00170
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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