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U.S. Department of Health and Human Services

Class 2 Device Recall ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Xray Systems

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 Class 2 Device Recall ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Xray Systemssee related information
Date Initiated by FirmNovember 10, 2008
Date PostedJanuary 08, 2009
Recall Status1 Terminated 3 on May 07, 2011
Recall NumberZ-0643-2009
Recall Event ID 50501
510(K)NumberK991103 K010390 
Product Classification Angiographic Injector and Syringe - Product Code DXT
ProductACIST 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.
Code Information Not associated with specific serial or lot numbers. Model: CVi Toshiba interface Cable, part number 700318-002.
FEI Number 3001726808
Recalling Firm/
Manufacturer		 Acist Medical Systems
7905 Fuller Rd
Eden Prairie MN 55344
For Additional Information Contact
952-995-9300
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Software design
ActionACIST 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 directed to either ACIST at 952-995-9300 or local Sales Reps or Clinical Applications Specialist.
Quantity in Commerce18 cables
DistributionWorldwide Distribution --- USA including states of AR, AZ, FL, and NY and countries of France, Germany, Italy, Japan, and Spain.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = DXT
510(K)s with Product Code = DXT
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