Oxygen Devices Recalled- Fire Hazard
Nidek Medical Products, Inc. has issued a Class I recall on oxygen concentrators due to problems with the device capacitors which could lead to device failure and fires. Oxygen concentrators are provided to oxygen patients who receive at home care.
“The reason for the field correction is due to a capacitor component inside the concentrators found in some instances to fail, which has resulted in residential and nursing home fires, and loss of supplemental oxygen supply,” FDA recall notice.
List of Recalled Oxygen Concentrators
- Nidek Medical Mark5 Nuvo / M5C5 Std, 115 V ~60Hz – 410W
- Nidek Medical Mark5 Nuvo / M5C5 Std, 230 V ~50/60Hz – 420W
- Nidek Medical Mark5 Nuvo / M5C5 OCSI, 115 V ~50/60Hz – 410W
- Nidek Medical Mark5 Nuvo / M5C5 OCSI, 230 V ~50/60Hz – 420W
- Nidek Medical Mark5 Nuvo 8 Std, 115 V ~60Hz – 500W
- Nidek Medical Mark5 Nuvo 8 OCSI, 230 V ~50/60Hz – 420W
- Nidek Medical Mark5 Nuvo Lite Model 520 Std, 115 V ~60Hz – 330W
- Nidek Medical Mark5 Nuvo Lite Model 525 OCSI, 115 V ~60Hz – 330W
- Nidek Medical Mark5 Nuvo Lite Model 920 Std, 230 V ~60Hz – 330W
- Nidek Medical Mark5 Nuvo Lite Model 925 OCSI, 230 V ~50Hz – 300W
- Nidek Medical Mark5 Nuvo Lite Model 925/60 OCSI, 230 V ~60Hz – 280W
Oxygen Concentrator Recall Information
- The recalled concentrators were manufactured by Nidek from January 2004 through May 2010.
- Consumers should let equipment providers know if their concentrators are affected.
- Customers with questions can contact Nidek Medical Products, Inc. at 1-205-856-7200 (extension 242).
- To report any problems with these products, consumers should notify the Food and Drug Administration at 1-800-FDA-1088.
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