The Recall Desk
SevereFDA (Devices)·Z-1779-2012·Announced 2012-06-27

Nidek Medical NUVO LITE Oxygen Concentrator Recalled for Fire Hazard

Nidek Medical is recalling 3,638 NUVO LITE 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 recall involves a fire hazard and loss of supplemental oxygen, which constitutes a significant injury risk and potential property damage, meeting the criteria for a Severe rating.

Plain-English summary

Nidek Medical Products Inc is recalling 3,638 units of the NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W Oxygen Concentrator. The recall covers serial numbers 042-10000 through 102-07044.

The recall was initiated because a capacitor failure may result in a fire hazard and loss of supplemental oxygen. The affected devices were distributed nationwide in the United States and in numerous countries worldwide, including Albania, Algeria, Australia, and others.

Consumers should stop using the affected oxygen concentrators immediately. They should contact Nidek Medical Products Inc for further instructions on how to resolve the issue.

The recalled product

Product
NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentrator.
Affected units
3,638

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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