Medtronic Navigation, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0926-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 31, 2013

Date Posted: March 20, 2013

Recall Number: Z-0926-2013

Event ID: 64256

Reason for Recall:

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

Status: Terminated

Product Quantity: 463 units

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 .

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.

Voluntary or Mandated:

Voluntary: Firm initiated