Events

Recall of Device Recall IMRIS Operating Room table (ORT200 and ORT300).

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by IMRIS 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
    69265
  • Event Risk Class
    Class 2
  • Event Number
    Z-0144-2015
  • Event Initiated Date
    2014-10-01
  • Event Date Posted
    2014-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130127
  • 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
    Table, operating-room, ac-powered - Product Code FQO
  • Reason
    One of the three pins that is used to hold the ort200 table alignment block in place on the floor of the mr suite went missing during testing at a health care facility.
  • Action
    Consignees were sent on 10/01/2014 an IMRIS "Urgent Field Safety Notice" letter dated September 25, 2014. The letter described the problem and the product involved in the recall. The letter informed consignees that the pins will be replaced with pins made of non-ferrous material. Customers are to ensure that users are aware of the changes and the existing procedure for table alignment and managing ferrous content in the magnet room. Contact customer support at 1-866-475-0525 for questions.

Device

Device Recall IMRIS Operating Room table (ORT200 and ORT300).
  • Model / Serial
    10006991, 10006997, 10005201, 10006891, 10004513, 10002692, 10004513, 10002220, 10007376, 10007377, 10002996, and 10002255.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including the states of CA, FL, NH, NC, TN, and UT; and, the countries of AUSTRALIA, CANADA, and JAPAN.
  • Product Description
    IMRIS Operating Room table (ORT200 and ORT300). || Intended for use during diagnostic examinations or surgical procedures to support and position a patient.
  • Manufacturer
    IMRIS Inc

Manufacturer

IMRIS Inc
  • Manufacturer Address
    IMRIS Inc, 5101 Shady Oak Rd S, Hopkins MN 55343-4100
  • Manufacturer Parent Company (2017)
    IMRIS Inc
  • Source
    USFDA