Drug recall
Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
FDA recall event 89767 · Class I · Respironics California, LLC
Key facts
| Event ID | 89767 |
|---|---|
| Recall numbers | Z-0907-2022, Z-0908-2022, Z-0909-2022 |
| Recalling firm | Respironics California, LLC |
| Product type | Devices |
| Products | Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276), Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709), Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Feb 28, 2022 |
| Report date | Apr 27, 2022 |
| City | Carlsbad |
| State | CA |
| Country | United States |
| FEI number | 3002470603 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: