FDA Device recall Z-1956-2013

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

FDA Device
Class II
terminated
Published 2013-08-21

On 2013-08-21 the FDA classified a Class II recall of StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and per… by Medtronic Navigation, citing 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….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1956-2013
Classification	Class II
Status	terminated
Initiated	2013-07-15
Published	2013-08-21
Last updated	2026-09-13 11:53 UTC
Company	Medtronic Navigation
Distribution	n/a

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.

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1956-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.