Philips Respironics V60 Plus Ventilator Part Number 1138747
Check against the official notice below — it lists the full affected range.
Respironics California, LLC is recalling 294 Philips Respironics V60 Plus Ventilators (Part Number 1138747) distributed across 13 U.S. states because a limited number were assembled with expired adhesive. If this adhesive fails, a bracket holding capacitors may loosen and potentially damage the capacitors, causing the ventilator to stop providing ventilation to the patient.
The hazard is particularly serious because the ventilator failure may either trigger both visual and audible alarms to alert users, or it may shut down silently without any alarm. The affected ventilators can be identified by their serial numbers beginning with "MX00," and the devices were distributed in Arkansas, California, Florida, Georgia, Indiana, Louisiana, Maryland, Missouri, New York, Pennsylvania, South Carolina, Tennessee, and Texas. The recall document does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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).
Reason for recall: 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). Distribution: U.S.: AR, CA, FL, GA, IN, LA, MD, MO, NY, PA, SC, TN and TX. O.U.S. N/A Quantity: 294 systems Lot/code info: 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/
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.