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Terminated

Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation, Inc., Littleton, MA 01460 (software version 3.0)

FDA Recall Z-0294-2008 · Posted 2007-11-27

Recalling FirmMedtronic Navigation, Inc
Recall StatusTerminated
Product CodeJZL
Date Initiated2007-10-17
Date Terminated2007-11-27
Product Quantity7 units

Reason for Recall

Reversed Instrument Position : a defect in the software version 3.0 causes an error in the position of surgical instruments and relative motion are reversed 180' on the StealthStation image. (If the StealthStation is not used, or if the patient orientation is prone or supine, the problem does not occur)

Firm Action

Medtronic Navigation notified customers by letter on October 17, 2007. Medtronic Field service will perform upgrade (software version 3.0.1) at user site.

Root Cause

Software change control

Distribution Pattern

Worldwide: USA including states of CO, IN, NE, and MN and countries of Canada and Germany

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050996O-ARM IMAGING SYSTEMBreakaway Imaging, LLC · 2005-05-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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