—#115675

Product

Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile

FDA product code: OXO — Image-Intensified Fluoroscopic X-Ray System, Mobile
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K092564
Affected lot / 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 .

Why it was recalled

Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Medtronic Navigation, Inc.
Address: 300 Foster St, Littleton, Massachusetts 01460-2017

Distribution

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.

Timeline

Recall initiated: 2013-01-31
Posted by FDA: 2013-03-08
Terminated: 2016-07-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115675. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.