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
    79360
  • Event Risk Class
    Class 2
  • Event Number
    Z-0976-2018
  • Event Initiated Date
    2018-02-20
  • 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=162121
  • 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 rotational locking mechanisms on the ort 100/ t2x tables can become disengaged or unlocked while in use which could potentially result in unintended movement of the table.
  • Action
    The firm disseminated the notices on 02/23/2018 and followed with emails on 02/26/2018. The notices stated: "To minimize the risk of injury, IMRIS is taking the following corrective actions: " ORT100 Table: The rotational locking mechanism shall be replaced in all ORT100 tables that do not contain the most current design. " T2X Table: Tables will have their rotational lock inspected. If components are worn or performance is other than intended, the rotational lock assembly will be serviced or replaced entirely. 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 including the fit of the covers, back section, headrest, pendant connection and swivel release pedal free engagement " During usage, verify the table is locked by manually pushing the table to make sure it does not move rotationally. " If the rotational lock is observed to be not functioning properly, please contact IMRIS Customer Service. The appropriate competent authorities have been notified of this corrective action. IMRIS is committed to patient and user safety, and apologizes for any inconvenience that this may cause. Please contact customer support via our service line at 1-866-475-0525 or Email: customersupport@i mris.com if you have any questions or concerns."

Device

Device Recall IMRIS T2X Table
  • Model / Serial
    Serial Numbers: 10000239, 10001306, 10000983, 10000982, 10000233, 10001119, 10001192, 10002375, 10003623, 10003623, 05 002, 10003634, 10001118, 10001188, 10001340, 10003638
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US, Canada, Australia, China, Qatar
  • Product Description
    IMRIS T2X Table, Part Number 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