Recall Z-0872-2015 ยท CAW Generator, Oxygen, Portable
Invacare Corporation
Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box.
| Date | Dec 24, 2014 (initiated Oct 31, 2014) |
| Status | Terminated |
| Reason | The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential fire hazard. |
| Root cause | Device Design |
| Action | The firm initiated a recall in Europe by notification to the regulatory authority on 10/31/2014. The firm will initiate a recall in the United States on 12/03/14 by distributing a customer notification letter. |
| Quantity | 138,446 units distributed globally |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020386 | INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02 Invacare Corp., Jul 2, 2002 |