Events

Recall of Device Recall Model 754/754M Disposable MRI Ventilator Circuit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Impact Instrumentation, Inc..

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
    59400
  • Event Risk Class
    Class 2
  • Event Number
    Z-3080-2011
  • Event Initiated Date
    2011-05-27
  • Event Date Posted
    2011-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102626
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    Ventilator Accessory, Continous - Product Code cbk
  • Reason
    Model 754/754 m disposable mri ventilator circuits are being distributed without market clearence (510k).
  • Action
    Impact Instrumentation Inc. sent an "Urgent Product Recall" dated May 27, 2011 to all affected customers. The letter informed customers the product is not a cleared product and to return the product back to Impact Inst. for credit. A notification form is included in the letter to be return to the firm. For information on this recall contact the firms Customer Service Department at (800) 969-0750, 8:30 am to 5:00 pm EST.

Device

Device Recall Model 754/754M Disposable MRI Ventilator Circuit
  • Model / Serial
    Catalog/Code # 820-0092-00
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution; including the states of CA, FL, IL, NJ, OH, TX, UT, MN, MO, MS, OH, OR, TX, AR, and PA.
  • Product Description
    Model 754/754M Disposable MRI Ventilator Circuit || Impact Instrumentation Inc., || 23 Fairfield Place, || West Caldwell, NJ 07006. || Accessory for 700 Series 754/754m Ventilators during MRI examinations
  • Manufacturer
    Impact Instrumentation, Inc.

Manufacturer

Impact Instrumentation, Inc.
  • Manufacturer Address
    Impact Instrumentation, Inc., 23 Fairfield Pl, West Caldwell NJ 07006-6206
  • Manufacturer Parent Company (2017)
    Asahi Kasei Corp.
  • Source
    USFDA