June 22 2012
- by Lucy Campbell
A Class I
has been issued for Nidek Medical Products Mark 5 Nuvo, Nuvo 8, and Nuvo Lite Oxygen Concentrators because a capacitor failure may result in a fire hazard and loss of supplemental oxygen. These products may cause serious adverse health consequences, including death.
Affected products include serial numbers from 042-10000 through 102-09335. These oxygen concentrators were manufactured from January 1, 2004 to May 15, 2010.
Oxygen concentrators are used to supply supplemental oxygen to patients within a home setting.
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