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U.S. Department of Health and Human Services

Class 2 Device Recall Critikon

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  Class 2 Device Recall Critikon see related information
Date Initiated by Firm November 16, 2000
Date Posted October 15, 2003
Recall Status1 Terminated 3 on May 03, 2012
Recall Number Z-0015-04
Recall Event ID 26278
Product Critikon brand Omni-Sat Adult, Semi-Disposable Sensor - P/N 009136
Code Information Lot 3910
Recalling Firm/
GE Medical Systems Information Technologies
4502 Woodland Corporate Blvd.
Tampa FL 33614
For Additional Information Contact Thomas English
Manufacturer Reason
for Recall
Instructions for use contained incorrect sensor reference.
FDA Determined
Cause 2
Action A recall notification letter with the correct 'Instructions for Use' attached, was mailed certified return receipt requested to accounts on 11/16/2000. Follow-up contact was made by mail or telephone until 100% response was completed. No return of product was requested but rather users were provided with the correct instructions for use.
Quantity in Commerce Total of 481
Distribution Product was distributed to 69 domestic hospitals nationwide including four military accounts. Also product was distributed 6 accounts in Canada, one in Thailand, one in Chile, one in Japan and one in singapore.

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.