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.
The agency’s classification
FDA (Devices): Class I
Class I is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- Manufacturer
- Nidek Medical Products Inc
- 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 →Related recalls
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See all →- SevereNidek Medical NUVO LITE Oxygen Concentrator Recalled for Fire Hazard
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- SevereNidek Medical Oxygen Concentrator Recalled for Fire Hazard
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- SevereNidek Medical Oxygen Concentrator Recalled for Fire Hazard
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- SevereNidek Medical NUVO LITE Oxygen Concentrator Recalled for Fire Hazard
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- SevereNidek Medical Oxygen Concentrator Recalled for Fire Hazard
FDA (Devices) · 2012-06-27
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