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U.S. Department of Health and Human Services

Class 2 Device Recall IMRIS ORT100 and ORT 200

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 Class 2 Recall
IMRIS ORT100 and ORT 200
see related information
Date Posted November 21, 2012
Recall Status1 Terminated on December 11, 2012
Recall Number Z-0428-2013
Recall Event ID 63500
Premarket Notification
510(K) Numbers
K061916  K071099  K083137 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.
Code Information 10002845, 10002341, 10003244, 10002794, 10003243, 10003629, 10003801, 10002654, 10002796, 10002795, 10002846, 10002847, 10003830, 10003064, 10005201,10003754, 10004513
Recalling Firm/
Manufacturer
Innovative Magnetic Resonance Imaging Systems Inc.
78 Innovation Drive
Winnipeg, Manitoba
Manufacturer Reason
for Recall
IMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not followed, the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the magnet approaches the table. This poses a potential risk of injury to both the patient and operators standing near the table.
FDA Determined
Cause 2
DESIGN: Labeling Design
Action Consignees were sent on 10/19/12 a IMRIS "Urgent Medical Device Correction" letter dated October 16. 2012. The letter described the product and the problem involved in the recall. It also provided changes to the Operator's Manual and labeling which addresses the issue. Customers may contact 1-866-475-0525.
Quantity in Commerce 23
Distribution Nationwide Distribution, including the states of FL, GA, IN, MD,MA, MI, MN, MO, TN, UT, and VA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = IMRIS, INC.
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