The Recall Desk
SevereFDA (Devices)·Z-1775-2012·Announced 2012-06-27

Nidek Medical Oxygen Concentrator Recalled for Fire Hazard

Nidek Medical is recalling M5C5/Mark5 Nuvo/OCSI oxygen concentrators because a capacitor failure may cause a fire and loss of supplemental oxygen.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source explicitly identifies a fire hazard and loss of supplemental oxygen, which constitutes a significant injury risk under the rubric for Severe recalls.

Plain-English summary

Nidek Medical Products Inc is recalling the NIDEK Medical M5C5/ MARK5 NUVO/OCSI oxygen concentrator (230 V~50/60 Hz -420 W). The recall involves units with serial numbers 042-10000 through 102-07044.

The recall is being conducted because a capacitor failure may result in a fire hazard and the loss of supplemental oxygen. This product was distributed nationwide in the United States and in numerous countries worldwide, including Albania, Algeria, Australia, Austria, Belgium, Bolivia, Bulgaria, Cambodia, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, England, France, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Iran, Ireland, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Kingdom of Saudi Arabia, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Mexico, Morocco, Myanmar, Namibia, Nepal, New Zealand, Nigeria, Pakistan, Peru, Philippines, Portugal, Republic of China, Republic of South Africa, Russia, Serbia, Singapore, Slovakia, South Africa, South Australia, South Korea, Spain, Switzerland, Taiwan, Tanzania, Thailand, The Netherlands, Togo, Tunisia, Turkey, Uganda, United Arab Emirates, and Vietnam.

Consumers should contact Nidek Medical Products Inc for further instructions on how to address this safety issue.

The recalled product

Product
NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator.
Manufacturer
Nidek Medical Products Inc
Category
Medical Device — Oxygen Concentrator
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial numbers 042-10000 through 102-07044

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by Nidek Medical Products Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Related recalls

Same manufacturer · Nidek Medical Products Inc

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Same hazard · fire

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