Enforcement Report - Week of November 28, 2012
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-0428-2013 |
| Classification | Class II |
| Code Info | 10002845, 10002341, 10003244, 10002794, 10003243, 10003629, 10003801, 10002654, 10002796, 10002795, 10002846, 10002847, 10003830, 10003064, 10005201,10003754, 10004513 |
| Product Distributed Qty | 23 |
| 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. |
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 | Letter |
| Distribution Pattern | Nationwide Distribution, including the states of FL, GA, IN, MD,MA, MI, MN, MO, TN, UT, and VA. |
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