Recall Z-2009-2009 ยท CAW Generator, Oxygen, Portable
Carleton Life Support Systems Inc
Cobham AMOGS Advanced Medical Oxygen Generating System, 70309-03900-101. Concentrator, Oxygen, Molecular Sieve, S/A P/N: 70309-03900-101, Mfg P/N 3261165-0101. The firm name on the label is Carleton Life Support Systems Inc., Davenport, IA.
| Date | Sep 16, 2009 (initiated Jul 24, 2009) |
| Status | Terminated |
| Reason | The backup oxygen supply control valve on the oxygen concentrator could fail resulting in it sticking in the open or closed positions. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 23 units |
| Distribution | Nationwide Distribution -- CT and AL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082829 | AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS) Carleton Life Support Systems, Inc., Dec 22, 2008 |