Portable Oxygen Generator
FDA device recall Z-1368-05 · posted 2005-08-12 · Terminated
Recall details
- Recalling firm
- Inogen, Inc
- Reason for recall
- Firm plans to upgrade all units to correct situations that could lead to interuption in oxygen delivery.
- Action taken
- Recall is scheduled to begin August 1st 2005 by letter to customers informing them that the units will be upgraded on a predetermined schedule. Firm estimates completion in 6 months.
- Root cause
- Other
- Status
- Terminated
- Product code
- CAW
- Quantity affected
- 900
- Distribution
- Nationwide
- Date initiated
- 2005-08-01
- Date posted
- 2005-08-12
- Date terminated
- 2007-02-13
- Location
- Goleta, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INOGEN ONE OXYGEN CONCENTRATOR (K032818) | Inogen, Inc. | 2004-05-13 |