FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2009-2009
- Recalling firm
- Carleton Life Support Systems 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.
- Status
- Terminated
- Initiated
- 2009-07-24
- Posted
- 2009-09-16
- Terminated
- 2012-03-22
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K082829"]
- PMA numbers
- not on file
- Product code
- CAW
- Firm FEI
- 3002840531
- Firm city
- Davenport
- Firm state
- IA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28