Recall Z-0909-2022— Respironics California, LLC
Class I · Ongoing
Class I FDA medical device recall by Respironics California, LLC, initiated 2022-02-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States. Reason: 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..
- Recalling firm
- Respironics California, LLC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2022-02-28
- Firm location
- Carlsbad, CA, United States
Product description
Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.