The Recall Desk
SevereFDA (Devices)·Z-1782-2012·Announced 2012-06-27

Nidek Medical Oxygen Concentrator Recalled for Fire Hazard

Nidek Medical is recalling MARK5 NUVO oxygen concentrators because a capacitor failure could cause a fire and stop oxygen supply.

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 recall involves a fire hazard and loss of life-sustaining oxygen, which constitutes a significant injury risk under the rubric for risk-of-harm products.

Plain-English summary

Nidek Medical Products Inc is recalling 18,114 units of the NIDEK Medical MARK5 NUVO / M5C5 oxygen concentrator. The recall covers serial numbers 042-10000 through 102-07044. These devices were distributed nationwide in the United States and in numerous countries worldwide.

The recall is being issued because a capacitor failure may result in a fire hazard and a loss of supplemental oxygen. This poses a risk to patients who rely on the device for respiratory support.

Consumers who have this product should contact Nidek Medical Products Inc for instructions on how to proceed with the recall.

The recalled product

Product
NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W. Oxygen Concentrator.
Affected units
18,114

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 →

Same manufacturer · Nidek Medical Products Inc

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