Recall Z-0288-2007 ยท CXT
Mallinckrodt Inc
OptiVantage DH Power Injection System.
| Date | Dec 16, 2006 (initiated Nov 7, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | The recalling firm sent a letter dated 11/7/2006 to all consignees. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042744 | OPTIV ANTAGE DH POWER INJECTION SYSTEM Mallinckrodt Inc., Liebel-Flarsheim Business, Nov 30, 2004 |