Class 2 Device Recall ORT300

• Date Initiated by Firm: August 25, 2021
• Create Date: September 28, 2021
• Recall Status: Terminated on April 30, 2024
• Recall Number: Z-2585-2021
• Recall Event ID: 88661
• Product Classification: Table, radiologic - Product Code KXJ
• Product: Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
• Code Information: UDI: 00857534006356 Model Number: 114093-000; Serial Numbers: 10005695, 10002998, 10005456, 10007377, 10002997, 10006737, 10004372, 10002841, 10005613, and 10002255.
• Recalling Firm/ Manufacturer: Deerfield Imaging, Inc.; 5101 Shady Oak Rd S; Minnetonka MN 55343-4100
• For Additional Information Contact: 866-475-0525
• Manufacturer Reason for Recall: ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
• FDA Determined Cause: Device Design
• Action: A Recall notification letter titled, "URGENT FIELD CORRECTION NOTICE" was sent to consignees on 08/25/2021 via Fed-Ex. E-mail communications were also sent to the customers on 8/26/2021. The letter instructs the consignee to fill out the second page of the notice and return it to the firm. The letter states that the IMRIS Customer Service will contact the consignee to schedule implementation of this corrective action with the facility. The letter mentions that, "IMRIS recommends these preventive actions: Per the OR Table 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 position is locked by manually pushing the table to ensure it does not exhibit rotational movement. If the rotational lock is observed to not function properly, please contact IMRIS Customer Service immediately."
• Quantity in Commerce: 10 units
• Distribution: Worldwide distribution - US Nationwide distribution FL, NH, TX, OH, CA, OR, UT, TN, NC and the countries of Canada, Australia, Sweden, Japan.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.