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Respironics California, LLC FDA Recalls
8 recalls on file across devices, 7 of them Class I and 8 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United StateClass IFeb 28, 2022Ventilator units have an issue impacting an internal electri |
| Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)Class IFeb 28, 2022Ventilator units have an issue impacting an internal electri |
| Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709Class IFeb 28, 2022Ventilator units have an issue impacting an internal electri |
| Philips Respironics V60 Plus Ventilator Part Number 1138747Class IJan 24, 2022A limited number of ventilators were assembled with expired |
| Philips Respironics V60 Ventilator Part Number 1053617Class IJan 24, 2022A limited number of ventilators were assembled with expired |
| Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus VentilatorClass IJun 18, 2021It has been identified that ventilators equipped with High F |
| Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is aClass IJun 18, 2021It has been identified that ventilators equipped with High F |
| PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is inteClass IIJan 6, 2021Due to unqualified "design verification" batteries being shi |