Recall Z-1956-2013— Medtronic Navigation, Inc.

Name: FDA recall Z-1956-2013
Creator: U.S. Food and Drug Administration
Published: 2013-07-15

Class II · Terminated

Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2013-07-15, terminated 2014-01-29. It names one FDA 510(k) clearance: K992927. Product: StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.. 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: Medtronic Navigation, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-07-15
Terminated: 2014-01-29
Firm location: Louisville, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K992927 — STEALTHSTATION TREATMENT GUIDANCE PLATFORMSurgical Navigation Technologies, Inc.·cleared 1999-12-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.