Recall Z-1778-2012— Nidek Medical Products Inc
Class I · Terminated
Class I FDA medical device recall by Nidek Medical Products Inc, initiated 2012-05-01, terminated 2017-03-21. FDA's recall record names no specific 510(k) clearance for this event. Product: NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentrator.. Reason: Capacitor failure may result in a fire hazard and loss of supplemental oxygen..
- Recalling firm
- Nidek Medical Products Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2012-05-01
- Terminated
- 2017-03-21
- Firm location
- Birmingham, AL, United States
Product description
NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentrator.
Reason for recall
Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
Data sourced from openFDA. This site is unofficial and independent of the FDA.