Z-2009-2009

Cobham AMOGS Advanced Medical Oxygen Generating System, 70309-03900-101. Concentrator, Oxygen, Molecular...

Name: Z-2009-2009 Cobham AMOGS Advanced Medical Oxygen Generating System, 70309-03900-101. Concentrator, Oxygen, Molecular...
Creator: Carleton Life Support Systems Inc
Published: 2009-07-24
License: https://open.fda.gov/license/

Mission Systems Davenport Inc. / initiated 2009-07-24 / Terminated / root cause: design

FDA source

Carleton Life Support Systems Inc began a recall of 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... on 2009-07-24. The reason FDA records is "The backup oxygen supply control valve on the oxygen concentrator could fail resulting in it sticking in the open or closed positions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2009-2009
Status: Terminated
Initiated: 2009-07-24
Posted: 2009-09-16
Terminated: 2012-03-22
Recalling firm: Mission Systems Davenport Inc.
Product: 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.
Product code: CAW Generator, Oxygen, Portable
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.
Root cause tag: design
FDA 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 in commerce: 23 units
Distribution: Nationwide Distribution -- CT and AL.
Product codes and lots: Serial Numbers: Qualification Unit - 99251000003454 and 99251000008047; and Production Units - 000036019, 000036336, 000036429, 000029395, 000037473, 99251000100933, 99251000101044, 99251000101224, 99251000101545, 99251000102031, 99251000102144, 99251000102523, 99251000102612, 99251000049251, 99251000104094, 99251000103934, 99251000104405, 99251000049252, 99251000049253, 99251000049254 and 99251000049255.

Product code CAW

K082829Class IIAircraft Medical Oxygen Generation System (Amogs)Carleton Life Support Systems, Inc. / cleared 2008-12-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)