Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
FDA Recall Z-0926-2013 · Posted 2013-03-08
Advertisement
Recalling FirmMedtronic Navigation, Inc.
Recall StatusTerminated
Product CodeOXO
Date Initiated2013-01-31
Date Terminated2016-07-06
Product Quantity463 units
Reason for Recall
Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction
Firm 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.
Root Cause
Component design/selection
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement