| | Class 2 Recall
Medtronic |  |
| Date Posted |
March 08, 2013 |
| Recall Number |
Z-0926-2013 |
| Product |
Medtronic O-arm Imaging System
Product Usage:
image-intensified fluoroscopic x-ray system, mobile |
| Code Information |
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 .
|
Recalling Firm/
Manufacturer |
Medtronic Navigation, Inc.
300 Foster St
Littleton, Massachusetts 01460-2017 |
Reason for
Recall |
Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction
|
| Action |
Medtronic Navigation issued a Field Safety Notice letter dated January 18, 2013 to all affected customers. The letter identified the affected product, problem, and actions to be taken. The letter instructed customers not to discontinue use and that a Medtronic Navigation Representative will be contacting them shortly to schedule a time to conduct the motion control box upgrade. For questions contact your local Medtronic Navigation representative or call Technical Services Group at 800-595-9709 or (720) 890-3200, or email at rs.navtechsupport@ medtronic.com. |
| Quantity in Commerce |
463 units |
| Distribution |
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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