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 | Letter |
| 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 |
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