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21-06-2012 | Article

Oxygen concentrators recalled for fire risk

Abstract

Recall notice

MedWire News: The Food and Drug Administration (FDA) has determined that a recall of 11 models of oxygen concentrators made by Nidek Medical Products, Inc. is a Class I recall, defined as "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."

According to Nidek, a capacitor inside the concentrators is subject to failure. The failure has resulted in residential and nursing home fires and the loss of the supplemental oxygen supplied by the units. There have been no reports to date of injuries due to product failures, the FDA says.

Oxygen concentrators are comparatively small, portable devices that may be used by some patients in place of supplemental oxygen tanks in a home or supervised residential setting, but are not intended for use as life-support devices.

Nidek reports that it is notifying distributors and customers of the recall and is arranging for field replacement of capacitors in the affected devices. The models affected were manufactured and distributed from January 2004 through May 2010, with serial numbers ranging from 042-10000 through 102-09335.

Specific models affected are:

1. Nuvo / M5C5 Std, 115 V ~60Hz - 410W

2. Nuvo / M5C5 Std, 230 V ~50/60Hz - 420W

3. Nuvo / M5C5 OCSI, 115 V ~50/60Hz - 410W

4. Nuvo / M5C5 OCSI, 230 V ~50/60Hz - 420W

5. Nuvo 8 Std, 115 V ~60Hz - 500W

6. Nuvo 8 OCSI, 230 V ~50/60Hz - 420W

7. Nuvo Lite Model 520 Std, 115 V ~60Hz - 330W

8. Nuvo Lite Model 525 OCSI, 115 V ~60Hz - 330W

9. Nuvo Lite Model 920 Std, 230 V ~60Hz - 330W

10. Nuvo Lite Model 925 OCSI, 230 V ~50Hz - 300W

11. Nuvo Lite Model 925/60 OCSI, 230 V ~60Hz - 280W.

Patients with the devices should notify their equipment providers, but may continue to use the devices while waiting for repairs, FDA and Nidek say.

Consumers with questions can contact Nidek Medical Products, Inc. at 1-205-856-7200 ext 242, or by email at fieldcorrection@nidekmedical.com.

By Neil Osterweil

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