Recent News
June 20, 2012
Nidek Medical Products, Inc. Issues an Urgent Medical Device Correction Affecting Oxygen Concentrators
The Missouri Department of Health and Senior Services received the following news release regarding the recall of oxygen concentrators. The recall 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.
The models affected include:
- 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
The affected devices were manufactured and distributed from January 2004 through May 2010 with serial numbers in the range of 042-10000 through 102-09335.
Use: Oxygen concentrators are normally used to supply supplemental oxygen to patients within a home setting. They are not considered to be life supporting devices.
The full recall, examples and pictures can be found at www.fda.gov/Safety/Recalls/ucm308840.htm.
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