Z-1998-2010

O-Arm Imaging System The O-Arm imaging system is a mobile X-Ray system designed for medical applications in...

Name: Z-1998-2010 O-Arm Imaging System The O-Arm imaging system is a mobile X-Ray system designed for medical applications in...
Creator: Medtronic Navigation, Inc.
Published: 2010-05-10
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2010-05-10 / Terminated / root cause: design

FDA source

Medtronic Navigation, Inc. began a recall of O-Arm Imaging System The O-Arm imaging system is a mobile X-Ray system designed for medical applications in surgical theaters, focusing on 3D imaging but also... on 2010-05-10. The reason FDA records is "The possibility that the real time image display can freeze up during use of a 2D continuous fluoroscopy". 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-1998-2010
Status: Terminated
Initiated: 2010-05-10
Posted: 2010-07-13
Terminated: 2011-10-07
Recalling firm: Medtronic Navigation, Inc
Product: O-Arm Imaging System The O-Arm imaging system is a mobile X-Ray system designed for medical applications in surgical theaters, focusing on 3D imaging but also offering 2D fluoroscopic Imaging.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: The possibility that the real time image display can freeze up during use of a 2D continuous fluoroscopy.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Medtronic, Inc., sent an "Urgent Field Safety Notice" letter dated May 10, 2010, to all custmers. The letter describes the product, problem and actions to be taken by customer. The firm recommended that the users of the O-Arm Imaging System reveiw the information provided to ensure patient safety remains uncompromised during use of the product. The customers were instructed to discontinue use and contact your local Medtronic Navigation representative or call our Technical Services Group at 800-595-9709 or (702) 890-3200, if the image is not updating as expected. A Medtronic Navigation representative will be contacting you within the coming months to schedule a time to evaluate and service the potentially affected components within your system. A service visit will also be scheduled starting November 2010 to update your system with a software based solution that will prevent this issue from occuring. If you have any questions about this notification, please contact your local Medtronic Navigation representative or call our Technical Services Group at 800-595-9709 or (702) 890-3200.
Quantity in commerce: 221
Distribution: Worldwide distribution: USA and countries of Germany, Singapore, South Africa, Poland, Libya, Belgium, Switzerland, Turkey, Italy, Denmark, France, Spain, Finland, Czech Republic, Ireland, Slovakia, the NetherLands, Austria, UAE, Kuwait, Israel, Australia, Sweden, Canada, South Korea, Japan and India.
Product codes and lots: Product Catalog Number: 9732719, 9733346, BI-700-00027-100, BI-70000027-120, BI-700-00027-230

Product code LLZ

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)