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U.S. Department of Health and Human Services

Class 2 Device Recall Advanced Medical Oxygen Generating Systems (AMOGS) Concentrator

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  Class 2 Device Recall Advanced Medical Oxygen Generating Systems (AMOGS) Concentrator see related information
Date Initiated by Firm July 24, 2009
Date Posted September 16, 2009
Recall Status1 Terminated 3 on March 22, 2012
Recall Number Z-2009-2009
Recall Event ID 52766
510(K)Number K082829  
Product Classification Generator, oxygen, portable - Product Code CAW
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Carleton Life Support Systems Inc
2734 Hickory Grove Rd
Davenport IA 52804-1203
For Additional Information Contact Vollie Rifner
563-383-6204
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CAW and Original Applicant = CARLETON LIFE SUPPORT SYSTEMS INC.
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