OptiVantage DH Power Injection System.

Company: Mallinckrodt Inc
Recall Initiated: November 7, 2006
Posted: December 16, 2006
Terminated: July 21, 2007
Recall Number: Z-0288-2007
Quantity: 1348 devices.
Firm Location: Cincinnati, OH

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.

Distribution

Worldwide distribution ---- including USA and countries of Australia, Belgium, Brazil, Canada, Chile, Columbia, Denmark, Mexico, Panama, Puerto Rico, Singapore and South Africa.