FDA-Device2023-10-04Class I
Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
Hazard
Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
Sold states
US Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines.
Affected count
15 (14 US; 1 OUS)
Manufactured in
1001 Murry Ridge Ln, N/A, Murrysville, PA, United States
Products
Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2631-2023More Philips Respironics, Inc. recalls
- FDA-Device2026-04-08Philips Respironics Trilogy Evo O2 ventilator recalled for delayed obstruction alarm
- FDA-Device2026-04-08Philips Respironics Trilogy Evo Universal ventilator recalled for delayed obstruction alarm
- FDA-Device2026-04-08Philips Respironics Trilogy EV300 ventilator recalled for delayed obstruction alarm
- FDA-Device2026-04-08Philips Respironics Trilogy Evo ventilator recalled for delayed obstruction alarm
- FDA-Device2026-04-01Philips Respironics Trilogy Evo ventilator recalled for inaccurate breath volume delivery with certain nebulizers
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