Nidek Medical Oxygen Concentrator Recalled for Fire Hazard
Nidek Medical is recalling 7,889 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 7,889 units of the NIDEK Medical M5C5/ MARK5 NUVO/STD Oxygen Concentrator. The affected devices have serial numbers ranging from 042-10000 through 102-07044. These units were distributed nationwide in the United States and in numerous countries worldwide.
The recall is being issued because a capacitor failure in the device may result in a fire hazard and a loss of supplemental oxygen. This poses a risk of injury or death to patients relying on the device for respiratory support.
Consumers should stop using the affected oxygen concentrators immediately and contact Nidek Medical Products Inc for further instructions on repair or replacement.
The recalled product
- Product
- NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator.
- Manufacturer
- Nidek Medical Products Inc
- Hazard
- Affected units
- 7,889
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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