Events

Recall of Device Recall OptiVantage DH Power Injection System.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mallinckrodt 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
    36811
  • Event Risk Class
    Class 2
  • Event Number
    Z-0288-2007
  • Event Initiated Date
    2006-11-07
  • Event Date Posted
    2006-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49391
  • 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
    Contrast Media Injection System - Product Code CXT
  • Reason
    The flow rate programmed on the console may be changed without automatically updating the flow rate programmed on the power head. the injector will always inject in accordance with the parameters shown on the power head. if this lack of synchronization occurs and is not noticed by the clinican, contrast would be injected at a higher or lower flow rate than desired.
  • Action
    The recalling firm sent a letter dated 11/7/2006 to all consignees.

Device

Device Recall OptiVantage DH Power Injection System.
  • Model / Serial
    All codes.
  • Product Classification
    Cardiovascular Devices
  • Distribution
    Worldwide distribution ---- including USA and countries of Australia, Belgium, Brazil, Canada, Chile, Columbia, Denmark, Mexico, Panama, Puerto Rico, Singapore and South Africa.
  • Product Description
    OptiVantage DH Power Injection System.
  • Manufacturer
    Mallinckrodt Inc

Manufacturer

Mallinckrodt Inc
  • Manufacturer Address
    Mallinckrodt Inc, 2111 E Galbraith Rd, Cincinnati OH 45237-1624
  • Source
    USFDA