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Terminated

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.

FDA Recall Z-0643-2009 · Posted 2009-01-08

Recalling FirmAcist Medical Systems
Recall StatusTerminated
Product CodeDXT
Date Initiated2008-11-10
Date Terminated2011-05-07
Product Quantity18 cables

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.

Firm 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 directed to either ACIST at 952-995-9300 or local Sales Reps or Clinical Applications Specialist.

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010390ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMSAcist Medical Systems, Inc. · 2001-03-09K991103MODIFICATION TO ACIST CL 100HAcist Medical Systems · 2000-05-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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