Recall Z-0643-2009 ยท DXT Injector And Syringe, Angiographic
Acist Medical Systems
ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Infinix-i cardiovascular X-ray system, Part Number 700318-002. The ACIST injection system is an angiographic injection system used in interventional cardiology, radiology, and vascular surgical procedures. The ACIST injection system supplies radiopaque contrast media to a catheter at a user-determined variable flow rate and
| Date | Jan 8, 2009 (initiated Nov 10, 2008) |
| Status | Terminated |
| Reason | Multiple Injections may result. It has been determined that when using the ACIST CVi Angiographic Injection system to synchronize with the Toshiba Infinix -i cardiovascular x-ray system there is an injection scenario that may result in multiple injections of contract media when one injection was intended. |
| Root cause | Software design |
| Action | ACIST is distributing an Urgent Medical Device Correction letter, dated November 10, 2008, to affected customers. The letter describes the issue and the scenario when the issue to occur, instructs them to discontinue use of the synchronized mode between the ACIST Angiographic Injection System model CVi and the Toshiba Infinix-i X-ray fluoroscopic system by disconnecting the interface cable immediately. The letter states that ACIST is working with Toshiba to resolve this issue. A response form is asked to be returned either by fax, e-mail or mail. If there are any questions, they should be |
| Quantity | 18 cables |
| Distribution | Worldwide Distribution --- USA including states of AR, AZ, FL, and NY and countries of France, Germany, Italy, Japan, and Spain. |
| FDA record | Open on fda.gov |