Nidek Medical Oxygen Concentrator Recalled for Fire Hazard
Nidek Medical is recalling 82 MARK5 NUVO 8 STD 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 under the rubric for Severe recalls.
Plain-English summary
Nidek Medical Products Inc is recalling 82 units of the NIDEK Medical MARK5 NUVO 8 STD oxygen concentrator (115 V~60Hz - 500W). The recall is due to a potential capacitor failure that may result in a fire hazard and the loss of supplemental oxygen.
The affected units have serial numbers ranging from 042-10000 through 102-07044. These devices were distributed nationwide in the United States and in numerous countries worldwide, including Albania, Algeria, Australia, Austria, Belgium, Bolivia, Bulgaria, Cambodia, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, England, France, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Iran, Ireland, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Kingdom of Saudi Arabia, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Mexico, Morocco, Myanmar, Namibia, Nepal, New Zealand, Nigeria, Pakistan, Peru, Philippines, Portugal, Republic of China, Republic of South Africa, Russia, Serbia, Singapore, Slovakia, South Africa, South Australia, South Korea, Spain, Switzerland, Taiwan, Tanzania, Thailand, The Netherlands, Togo, Tunisia, Turkey, Uganda, United Arab Emirates, and Vietnam.
Consumers should stop using the affected oxygen concentrators immediately and contact Nidek Medical Products Inc for instructions on how to proceed with the recall.
The recalled product
- Product
- NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W. Oxygen Concentrator.
- Manufacturer
- Nidek Medical Products Inc
- Affected units
- 82
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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