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U.S. Department of Health and Human Services

Class 2 Device Recall Teledyne Analytical Instruments

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  Class 2 Device Recall Teledyne Analytical Instruments see related information
Date Initiated by Firm October 27, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on February 20, 2004
Recall Number Z-0145-04
Recall Event ID 27593
Product Classification Analyzer, Gas, Oxygen, Gaseous-Phase - Product Code CCL
Product Portable Oxygen Analyzer
Code Information Model AX300, Model MX300
Recalling Firm/
Manufacturer		 Teledyne Analytical Instruments
16830 Chestnut St
Rowland Heights CA 91748-1017
For Additional Information Contact Ray Khajavi
949-934-1502
Manufacturer Reason
for Recall		 Potential failure to display the battery low light to the end-user.
FDA Determined
Cause 2		 Other
Action All affected customers will be notified by letter on 10/27/2003. All units returned will be reworked and 100% retested prior to shipment.
Quantity in Commerce 170
Distribution FL, CA, UT, AZ and MO. New Zealand, Australia, Canada and the United Kingdom
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.
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