FDA Device recall Z-1775-2012
NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator
- FDA Device
- Class I
- terminated
- Published 2012-06-27
On 2012-06-27 the FDA classified a Class I recall of NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator by Nidek Medical Products, citing capacitor failure may result in a fire hazard and loss of supplemental oxygen.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1775-2012 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-05-01 |
| Published | 2012-06-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nidek Medical Products |
| Distribution | US |
Product
NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator.
Reason
Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
Identifiers
| code_info | Serial numbers 042-10000 through 102-07044 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1775-2012%22
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