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U.S. Department of Health and Human Services

Class 2 Device Recall OptiVantage DH Power Injection System.

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  Class 2 Device Recall OptiVantage DH Power Injection System. see related information
Date Initiated by Firm November 07, 2006
Date Posted December 16, 2006
Recall Status1 Terminated 3 on July 21, 2007
Recall Number Z-0288-2007
Recall Event ID 36811
510(K)Number K042744  
Product Classification Contrast Media Injection System - Product Code CXT
Product OptiVantage DH Power Injection System.
Code Information All codes.
Recalling Firm/
Mallinckrodt Inc
2111 E Galbraith Rd
Cincinnati OH 45237-1624
For Additional Information Contact Dale Moore
Manufacturer Reason
for Recall
The flow rate programmed on the console may be changed without automatically updating the flow rate programmed on the power head. The injector will always inject in accordance with the parameters shown on the power head. If this lack of synchronization occurs and is not noticed by the clinican, contrast would be injected at a higher or lower flow rate than desired.
FDA Determined
Cause 2
Action The recalling firm sent a letter dated 11/7/2006 to all consignees.
Quantity in Commerce 1348 devices.
Distribution Worldwide distribution ---- including USA and countries of Australia, Belgium, Brazil, Canada, Chile, Columbia, Denmark, Mexico, Panama, Puerto Rico, Singapore and South Africa.

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 = CXT and Original Applicant = MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS