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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Event Detail

Event ID 63500
Product Type Devices
Status Ongoing
Recalling Firm Innovative Magnetic Resonance Imaging Systems Inc.
City Winnipeg
State MB
Country CA
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-19
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution, including the states of FL, GA, IN, MD,MA, MI, MN, MO, TN, UT, and VA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 10002845, 10002341, 10003244, 10002794, 10003243, 10003629, 10003801, 10002654, 10002796, 10002795, 10002846, 10002847, 10003830, 10003064, 10005201,10003754, 10004513 Class II 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. 23 Z-0428-2013