Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box.
FDA Recall Z-0872-2015 · Posted 2014-12-24
Advertisement
Recalling FirmInvacare Corporation
Recall StatusTerminated
Product CodeCAW
Date Initiated2014-10-31
Date Terminated2017-02-07
Product Quantity138,446 units distributed globally
Reason for Recall
The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential fire hazard.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement