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.
FDA Recall Z-1849-2012 · Posted 2012-06-21
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Recalling FirmMedtronic Navigation, Inc.
Recall StatusTerminated
Product CodeIZL
Date Initiated2010-10-12
Date Terminated2012-06-21
Product Quantity3 units
Reason for Recall
Software Version 3.1.1 does not meet navigational accuracy.
Firm 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.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution including the states of CO, IN, and MN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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