Company: Medtronic Navigation, Inc.
Date of Enforcement Report: 8/21/2013
Class ll:
PRODUCT
StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.
Recall Number Z-1956-2013
REASON
Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5.4 which can be used on Medtronic Navigation StealthStation 57 and i7 systems or a Medtronic Planning Station due to the potential of discrepancy between the exam image and the displayed measurement or overlay under certain conditions of use.
RECALLING FIRM/MANUFACTURER
Medtronic Navigation, Inc. Louisville CO on 7/15/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
572
DISTRIBUTION
Nationwide and Internationally
___________________________________
