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U.S. Department of Health and Human Services

Class 2 Device Recall IMRIS Operating Room table (ORT200 and ORT300).

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  Class 2 Device Recall IMRIS Operating Room table (ORT200 and ORT300). see related information
Date Initiated by Firm October 01, 2014
Date Posted October 28, 2014
Recall Status1 Terminated 3 on February 20, 2015
Recall Number Z-0144-2015
Recall Event ID 69265
Product Classification Table, operating-room, ac-powered - Product Code FQO
Product IMRIS Operating Room table (ORT200 and ORT300).

Intended for use during diagnostic examinations or surgical procedures to support and position a patient.
Code Information 10006991, 10006997, 10005201, 10006891, 10004513, 10002692, 10004513, 10002220, 10007376, 10007377, 10002996, and 10002255.
Recalling Firm/
Manufacturer		 IMRIS Inc
5101 Shady Oak Rd S
Hopkins MN 55343-4100
Manufacturer Reason
for Recall		 One of the three pins that is used to hold the ORT200 table alignment block in place on the floor of the MR Suite went missing during testing at a health care facility.
FDA Determined
Cause 2		 Use error
Action Consignees were sent on 10/01/2014 an IMRIS "Urgent Field Safety Notice" letter dated September 25, 2014. The letter described the problem and the product involved in the recall. The letter informed consignees that the pins will be replaced with pins made of non-ferrous material. Customers are to ensure that users are aware of the changes and the existing procedure for table alignment and managing ferrous content in the magnet room. Contact customer support at 1-866-475-0525 for questions.
Quantity in Commerce 14
Distribution Worldwide Distribution -- USA, including the states of CA, FL, NH, NC, TN, and UT; and, the countries of AUSTRALIA, CANADA, and 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.
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