Cobham AMOGS Advanced Medical Oxygen Generating System, 70309-03900-101. Concentrator, Oxygen, Molecular Sieve, S/A P/N:
FDA device recall Z-2009-2009 · posted 2009-09-16 · Terminated
Recall details
- Recalling firm
- Carleton Life Support Systems Inc
- Reason for recall
- The backup oxygen supply control valve on the oxygen concentrator could fail resulting in it sticking in the open or closed positions.
- Action taken
- Cobham Life Support Systems, Inc. issued letters to their two customers via e-mail. One customer letter was dated July 24, 2009 and the other was dated July 28, 2009. Both letters notified the customer of the reason for the recall and that the usage of the concentrator must be restricted to exclude actual use with a patient until corrected. The letter informs customers they are redesigning the backup supply control valve and will coordinate the retrofit in the future. For further information, contact Cobham Life Support at 1-563-383-6421.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CAW
- Quantity affected
- 23 units
- Distribution
- Nationwide Distribution -- CT and AL.
- Date initiated
- 2009-07-24
- Date posted
- 2009-09-16
- Date terminated
- 2012-03-22
- Location
- Davenport, IA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS) (K082829) | Carleton Life Support Systems, Inc. | 2008-12-22 |