The Recall Desk
SevereFDA (Devices)·Z-1777-2012·Announced 2012-06-27

Nidek Medical Oxygen Concentrator Recalled for Fire Hazard

Nidek Medical is recalling 335 MARK5 NUVO 8 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 life-support oxygen, which constitutes a significant injury risk under the rubric for Severe recalls.

Plain-English summary

Nidek Medical Products Inc is recalling 335 units of the NIDEK Medical MARK5 NUVO 8 /OCSI oxygen concentrator. The affected devices are 230 V~50/60Hz - 420 W models with serial numbers ranging from 042-10000 through 102-07044.

The recall was initiated because a capacitor failure in these devices may result in a fire hazard and the loss of supplemental oxygen. This poses a risk of injury or death to patients relying on the equipment for respiratory support.

The affected units were distributed worldwide, including in the United States and numerous international locations. Consumers who possess these specific serial numbers should stop using the devices and contact Nidek Medical Products Inc for further instructions.

The recalled product

Product
NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W. Oxygen Concentrator.
Affected units
335

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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