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.
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 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.
- Manufacturer
- Nidek Medical Products Inc
- Hazard
- 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 →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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- Severe
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