Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Acist Medical Systems.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    50501
  • Event Risk Class
    Class 2
  • Event Number
    Z-0643-2009
  • Event Initiated Date
    2008-11-10
  • Event Date Posted
    2009-01-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75534
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Angiographic Injector and Syringe - Product Code DXT
  • 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.
  • 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.

Device

Device Recall ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Xray Systems
  • Model / Serial
    Not associated with specific serial or lot numbers. Model: CVi Toshiba interface Cable, part number 700318-002.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of AR, AZ, FL, and NY and countries of France, Germany, Italy, Japan, and Spain.
  • Product Description
    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.
  • Manufacturer
    Acist Medical Systems

Manufacturer

Acist Medical Systems
  • Manufacturer Address
    Acist Medical Systems, 7905 Fuller Rd, Eden Prairie MN 55344
  • Manufacturer Parent Company (2017)
    Bracco Spa
  • Source
    USFDA