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U.S. Department of Health and Human Services

Class 2 Device Recall IMRIS ORT300 Removable Operating Room Table

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  Class 2 Device Recall IMRIS ORT300 Removable Operating Room Table see related information
Date Initiated by Firm February 23, 2018
Create Date March 27, 2018
Recall Status1 Terminated 3 on August 27, 2019
Recall Number Z-1218-2018
Recall Event ID 79366
Product Classification Table, operating-room, ac-powered - Product Code FQO
Product IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.
Code Information Serial numbers: 10005695, 10002998, 10005456, 10007411, 10007377, 10002997, 10002996, 10005612, 10004372, 10002841, 10004515, 10005613, 10002255  
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 200/300 tables fail to operate such that it cannot change states between locked and unlocked.
FDA Determined
Cause 2		 Under Investigation by firm
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."
Quantity in Commerce 13 units
Distribution US, Canada, China, Sweden, Germany, Japan, Qatar, France, Audtralia
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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