CLASS II Device recall · Reported 20 Mar 2013 · FDA Enforcement Report

Medtronic O-arm Imaging System recalled by Medtronic Navigation

Medtronic Navigation is recalling Medtronic O-arm Imaging System, distributed nationwide in the US. The recall was initiated on 31 Jan 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct 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 .

Quantity recalled463 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0926-2013
FDA event ID: 64256
Recalling firm: Medtronic Navigation, Littleton, MA
Classification: Class II
Status: Terminated
Recall initiated: 31 Jan 2013
FDA classified: 8 Mar 2013
Reported: 20 Mar 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

31 Jan 2013	Recall initiated by company
8 Mar 2013	Classified by FDA	+36 days
20 Mar 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide

Questions about this recall

Is Medtronic O-arm Imaging System recalled?

Yes. Medtronic Navigation recalled Medtronic O-arm Imaging System on 31 Jan 2013. The recall is Class II and its status is Terminated. Recall number Z-0926-2013.

Why was it recalled?

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

Which lots are affected?

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 .

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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