Class 2 Device Recall OptiVantage DH Power Injection System.

• Date Initiated by Firm: November 07, 2006
• Date Posted: December 16, 2006
• Recall Status: Terminated 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.
• FEI Number: 1518293
• Recalling Firm/ Manufacturer: Mallinckrodt Inc; 2111 E Galbraith Rd; Cincinnati OH 45237-1624
• For Additional Information Contact: Dale Moore; 513-948-5771
• 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: Other
• 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