Events

Recall of Device Recall IMRIS ORT200 Removable Operating Room 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
    79366
  • Event Risk Class
    Class 2
  • Event Number
    Z-1217-2018
  • 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=162136
  • 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 200/300 tables fail to operate such that it cannot change states between locked and unlocked.
  • Action
    The firm disseminated their notices on 02/23/2018 by mail and followed with an email on 02/26/2018. The notice stated: "It has recently come to our attention that the ORT200/300 rotational lock fails to operate such that it cannot change states between locked and unlocked. This may pose a risk of injury to the patient. To minimize the risk of injury, IMRJS is taking the following corrective actions: " ORT200 and 300 tables: all customer sites with these tables shall have the rotational lock operation verified and adjusted, if necessary. 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 OAT Operator Manuals the table should be tested daily in all standard positions and inspected for anomalies including the fit of the covers, tabletops, headrest, pendant connection and rotation. " 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@imris. com if you have any questions or concerns."

Device

Device Recall IMRIS ORT200 Removable Operating Room Table
  • Model / Serial
    Serial numbers: 10006997, 10002692, 10006152, 10007192, 10006991, 10002220, 10003754, 10006997, 10004513, 10005201, 10006891, 10004463, 10005189, 10005190, 10004327, 10004997, 10006891
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US, Canada, China, Sweden, Germany, Japan, Qatar, France, Audtralia
  • Product Description
    IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.
  • 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