Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive.
FDA device recall Z-0768-2013 · posted 2013-02-02 · Terminated
Recall details
- Recalling firm
- Oxus America, Inc.
- Reason for recall
- Due to past battery inventory storage conditions and deficiencies in the maintenance procedure, it was possible that some batteries were over-discharged to point of damaging the cells.
- Action taken
- Oxus, Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 11, 2013 to all affected customers.The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-888-475-1568 for information related to this recall.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CAW
- Quantity affected
- 1724 total units
- Distribution
- Worldwide Distribution-USA including the states of New York, Michigan, Colorado, Texas, Iowa, Florida, Georgia, Ohio, Wisconsin, Oregon, Alabama, Illinois, Utah, Oklahoma, West Virginia and California
- Date initiated
- 2013-01-14
- Date posted
- 2013-02-02
- Date terminated
- 2013-07-17
- Location
- Rochester Hills, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFESTYLE OXYGEN CONCENTRATOR (K020324) | Airsep Corp. | 2002-03-13 |