Events

Recall of Device Recall IMRIS T2X Table

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Deerfield Imaging, 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
    79488
  • Event Risk Class
    Class 2
  • Event Number
    Z-1265-2018
  • Event Initiated Date
    2018-02-23
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162457
  • 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
    The operating room table may drift while in use, which could potentially result in unintended movement of the table.
  • Action
    The firm initiated their field notification on 02/23/2018 by letter. The notice stated the following: "It has recently come to our attention that the ORTT2X/100/200/300 tables may drift while in use, which could potentially result in unintended movement of the table. This may pose a risk of injury to the patient. To minimize these risks, IMRIS is taking the following corrective actions: " ORT T2X/100/200 tables: The tables will be tested for drift symptoms. No further action will occur for tables that pass the drift test. For tables that do not pass the drift test, a hydraulc fluid flush and filter change will be performed. " ORT300 tables: all customer sites with these tables shall have the hydraulic fluid flushed and exchanged for new and the filter element will be changed.A drift test will also be performed. IMRIS has identified that your facility has one or more of these OR Tables which require evaluation. Please confirm details on page 2 and return your response to IMRIS. IMRIS Customer Service will contact you to implement this corrective action. IMRIS recommends these preventive actions: " Per the ORT Operator Manuals, the table should be tested daily in all standard positions and inspected for anomalies. Before each surgery, inspect the table for any visibly loose components or hydraulic fluid leaks and check that the headrest and tabletop safety latches are secured. .Please contact customer support via our service line at 1-866-475-0525 or Email: customersupport@imris.com if you have any questions or concerns."

Device

Device Recall IMRIS T2X Table
  • Model / Serial
    (a) 108000-000, Serial Numbers: 10000239, 10000983, 10000233 (b) 108000-600, Serial Numbers: 10001306 (c) 109682-000, Serial Numbers: 10002375, 10001118, 10001340 (d) 109682-600, Serial Numbers: 10001119, 10003623, 05-002, 10003634, 10001188, 10003638, 10001192
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US, Canada, China, Australia, Sweden, Germany
  • Product Description
    IMRIS T2X Table, Part Numbers: || (a) 108000-000 || (b) 108000-600 || (c) 109682-000 || (d) 109682-600
  • Manufacturer
    Deerfield Imaging, Inc.

Manufacturer

Deerfield Imaging, Inc.
  • Manufacturer Address
    Deerfield Imaging, Inc., 5101 Shady Oak Rd S, Minnetonka MN 55343-4100
  • Manufacturer Parent Company (2017)
    Deerfield Management Company L.P.
  • Source
    USFDA