Enforcement Report - Week of March 20, 2013
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Product Detail
| Product Description | Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile |
|---|---|
| Recall Number | Z-0926-2013 |
| Classification | Class II |
| Code Info | Product Catalog Numbers: 9732719, 9732719R, 9733346, 9733346R, BI-700-00027, BI-700-00027R, BI-700-00027-GER, BI-700-00027-GERR, BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R Units with serial numbers 101 through 564 and unit 580 are affected. Serial numbers 565 and higher are not affected . |
| Product Distributed Qty | 463 units |
| Reason For Recall | Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction |
Event Detail
| Event Id | 64256 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Medtronic Navigation, Inc. |
| City | Littleton |
| State | MA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2013-01-31 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution - USA Nationwide and the countries of: Canada, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CHILE, CHINA, CROATIA, CZECH REPUBLIC, DENMARK,FINLAND, FRANCE, GERMANY, GREECE, INDIA, IRELAND, ISRAEL, ITALY, JAPAN ,KOREA, REPUBLIC OF KUWAIT, LEBANON, LIBYAN ARAB JAMAHIRIYA, MEXICO, NETHERLANDS, New Zealand, POLAND, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, Taiwan(R.O.C.) , THAILAND, TURKEY, UNITED ARAB EMIRATES. and UNITED KINGDOM. |
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