Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box.
FDA device recall Z-0872-2015 · posted 2014-12-24 · Terminated
Recall details
- Recalling firm
- Invacare Corporation
- Reason for recall
- The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential fire hazard.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CAW
- Quantity affected
- 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.
- Date initiated
- 2014-10-31
- Date posted
- 2014-12-24
- Date terminated
- 2017-02-07
- Location
- Elyria, OH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02 (K020386) | Invacare Corp. | 2002-07-02 |