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U.S. Department of Health and Human Services

Class 2 Device Recall IMRIS ORT100 Table

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  Class 2 Device Recall IMRIS ORT100 Table see related information
Date Initiated by Firm February 20, 2018
Create Date March 13, 2018
Recall Status1 Terminated 3 on August 27, 2019
Recall Number Z-0975-2018
Recall Event ID 79360
Product Classification Table, radiologic - Product Code KXJ
Product IMRIS ORT100 Table, Part Number 110470-000
Code Information Serial Numbers: 10002341, 10003629, 10003801, 10002654, 10002795, 10002796, 10002847, 10003830, 10003243, 10002848, 10003241, 10005651, 10007348, 10007424, 10006886  
Recalling Firm/
Manufacturer		 Deerfield Imaging, Inc.
5101 Shady Oak Rd S
Minnetonka MN 55343-4100
For Additional Information Contact customer support
866-475-0525
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Device Design
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."
Quantity in Commerce 15 tables
Distribution US, Canada, Australia, China, Qatar
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.
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