Medtronic Navigation, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1956-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 15, 2013

Date Posted: August 21, 2013

Recall Number: Z-1956-2013

Event ID: 65743

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.

Status: Terminated

Product Quantity: 572

Code Information:

Lot number(s): Not applicable; All kits containing the Framelink Software version 5.4 are affected by this corrective action.

Distribution Pattern:

Worldwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated