FDA-Device2014-12-31Class II

Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box.

Invacare Corporation
Hazard

The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential fire hazard.

Sold states
The product was distributed throughout the U.S. and to foreign countries, including Canada and other countries TBD. The affected product was also distributed to eight government consignees.
Affected count
138,446 units distributed globally
Manufactured in
1200 Taylor St, Elyria, OH, United States
Products
Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0872-2015

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