Enforcement Report - Week of August 29, 2012
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Product Detail
| Product Description | Medtronic O-arm® Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R. |
|---|---|
| Recall Number | Z-2244-2012 |
| Classification | Class II |
| Code Info | Serial Numbers: 109R, 118R, 124, 136, 159 ,170, 218, 222, 223, 236, 239 , 299, 309R, 402, 410, 412, 414. |
| Product Distributed Qty | 17 units |
| Reason For Recall | A fault in a high voltage relay in the 0-arm® Imaging System might cause the relay to overheat and burn. |
Event Detail
| Event Id | 62571 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Medtronic Navigation, Inc. |
| City | Littleton |
| State | MA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-11 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution - USA, including the states of AL, CO, FL, IA, MI, IA, NC, NE, NY and the countries of South Africa, Italy, and Spain. |
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