Device Recall ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Xray Systems

Not associated with specific serial or lot numbers. Model: CVi Toshiba interface Cable, part number 700318-002.

Cardiovascular Devices

2

No

Worldwide Distribution --- USA including states of AR, AZ, FL, and NY and countries of France, Germany, Italy, Japan, and Spain.

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 volume which can be instantaneously and continuously varied. Manufactured by: ACIST Medical Systems, Inc., 7905 Fuller Road, Eden Prairie, MN 55344, USA. The ACIST CVi injection system is able to synchronize with certain X-ray imaging systems from Siemens, Toshiba, GE and Philips. || Intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.