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U.S. Department of Health and Human Services

Class 2 Device Recall IMRIS T2X Table

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  Class 2 Device Recall IMRIS T2X Table see related information
Date Initiated by Firm February 23, 2018
Create Date March 28, 2018
Recall Status1 Terminated 3 on September 12, 2019
Recall Number Z-1265-2018
Recall Event ID 79488
Product Classification Table, operating-room, ac-powered - Product Code FQO
Product IMRIS T2X Table, Part Numbers:
(a) 108000-000
(b) 108000-600
(c) 109682-000
(d) 109682-600
Code Information (a) 108000-000, Serial Numbers: 10000239, 10000983, 10000233 (b) 108000-600, Serial Numbers: 10001306 (c) 109682-000, Serial Numbers: 10002375, 10001118, 10001340 (d) 109682-600, Serial Numbers: 10001119, 10003623, 05-002, 10003634, 10001188, 10003638, 10001192
Recalling Firm/
Manufacturer		 Deerfield Imaging, Inc.
5101 Shady Oak Rd S
Minnetonka MN 55343-4100
For Additional Information Contact
763-203-6300
Manufacturer Reason
for Recall		 The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.
FDA Determined
Cause 2		 Other
Action The firm initiated their field notification on 02/23/2018 by letter. The notice stated the following: "It has recently come to our attention that the ORTT2X/100/200/300 tables may drift while in use, which could potentially result in unintended movement of the table. This may pose a risk of injury to the patient. To minimize these risks, IMRIS is taking the following corrective actions: " ORT T2X/100/200 tables: The tables will be tested for drift symptoms. No further action will occur for tables that pass the drift test. For tables that do not pass the drift test, a hydraulc fluid flush and filter change will be performed. " ORT300 tables: all customer sites with these tables shall have the hydraulic fluid flushed and exchanged for new and the filter element will be changed.A drift test will also be performed. 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. Before each surgery, inspect the table for any visibly loose components or hydraulic fluid leaks and check that the headrest and tabletop safety latches are secured. .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."
Quantity in Commerce 14 units
Distribution US, Canada, China, Australia, Sweden, Germany
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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