Recall Z-0288-2007
Mallinckrodt Inc · initiated November 7, 2006
Product
OptiVantage DH Power Injection System.
Codes / lots: All codes.
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 taken
The recalling firm sent a letter dated 11/7/2006 to all consignees.
Details
- Recall number
- Z-0288-2007
- Initiated
- November 7, 2006
- Posted by FDA
- December 16, 2006
- Terminated
- July 21, 2007
- Quantity
- 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.
- Recalling firm
- Mallinckrodt Inc, Cincinnati, OH