Z-0926-2013Class II

Medtronic O-arm Imaging System

Name: Z-0926-2013 Medtronic O-arm Imaging System
Creator: Medtronic Navigation, Inc.
Published: 2013-01-31
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2013-01-31 / Terminated / root cause: design

FDA source

Medtronic Navigation, Inc. began a recall of Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile on 2013-01-31. FDA classified it as Class II and gives the reason as "Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0926-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-31
Posted: 2013-03-08
Terminated: 2016-07-06
Recalling firm: Medtronic Navigation, Inc
Product: Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
Product code: OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Reason for recall: Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction
Root cause tag: design
FDA root cause: Component design/selection
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.
Product codes and lots: 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 .

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0926-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0926-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-08

Product code OXO

K092564Class IIO-Arm Imaging SystemMedtronic Navigation, Inc. (Littleton) / cleared 2010-06-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)