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FDA (Device enforcement)Recalled 2022-02-28class i

Respironics California, LLC: Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R

Is my product affected?

Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)

  • UPC 00884838009844
  • UPC 00884838009851
  • UPC 00884838020054
  • UPC 00884838025776
  • UPC 00884838089280
  • UPC 00884838090996

Check against the official notice below — it lists the full affected range.

What happened

Philips Respironics is recalling approximately 87,138 units of the V60 Ventilator across all models due to an issue with an internal electrical circuit that could cause the ventilator to stop operating in some cases. The affected ventilators have been distributed nationwide throughout the United States and in numerous countries worldwide.

The record does not specify a remedy for consumers who own affected units.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.

Details from the source

Reason for recall: Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate. Distribution: Worldwide distribution US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Afghanistan, Albania, Algeria, American Samoa, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgi Quantity: 87,138 units Lot/code info: All Lots & Serial Numbers. V60 UDI-DI: 00884838009844, 00884838009851, 00884838020054, 00884838025776, 00884838089280, 00884838090996.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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