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U.S. Department of Health and Human Services

Class 2 Device Recall ORT300

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  Class 2 Device Recall ORT300 see related information
Date Initiated by Firm August 25, 2021
Create Date September 28, 2021
Recall Status1 Completed
Recall Number Z-2586-2021
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: 00857534006462; Model Number: 114093-600; Serial Number: 10007411, 10002996, 10004515.
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 2		 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 3 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.
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