Z-1849-2012Class II

Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and...

Name: Z-1849-2012 Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and...
Creator: Medtronic Navigation, Inc.
Published: 2010-10-12
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2010-10-12 / Terminated / root cause: software

FDA source

Medtronic Navigation, Inc. began a recall of Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm Imaging System is a mobile x-ray... on 2010-10-12. FDA classified it as Class II and gives the reason as "Software Version 3.1.1 does not meet navigational accuracy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1849-2012
Classification: Class II
Status: Terminated
Initiated: 2010-10-12
Posted: 2012-06-21
Terminated: 2012-06-21
Recalling firm: Medtronic Navigation, Inc
Product: Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.
Product code: IZL System, X-Ray, Mobile
Reason for recall: Software Version 3.1.1 does not meet navigational accuracy.
Root cause tag: software
FDA root cause: Software design
Action: Medtronic Navigation contacted customers by telephone on 10/12/2010 and with "Urgent Field Safety Notice" follow up letters dated 10/14 or 10/15/2010. Sites were visited by Medtronic Service Representative to complete navigational accuracy testing and either replace or correct the unit.
Quantity in commerce: 3 units
Distribution: Nationwide Distribution including the states of CO, IN, and MN.
Product codes and lots: Serial Numbers: 125, 156, 234R.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1849-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1849-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-21

Product code IZL

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)