Z-1956-2013Class II

StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning...

Name: Z-1956-2013 StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning...
Creator: Medtronic Navigation, Inc.
Published: 2013-07-15
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2013-07-15 / Terminated / root cause: software

FDA source

Medtronic Navigation, Inc. began a recall of StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures on 2013-07-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1956-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-15
Posted: 2013-08-13
Terminated: 2014-01-29
Recalling firm: Medtronic Navigation, Inc
Product: StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.
Product code: HAW Neurological Stereotaxic Instrument
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.
Root cause tag: software
FDA root cause: Software design
Action: A Field Safety Notice was sent on 7/15/13 to users informing them that the Framelink software version 5.4 has been revised to correct the software anomalies described in this letter. A new version will be installed on their system(s) by a Medtronic Navigation representative. Until the software upgrade has been installed on their system, do not use high resolution examinations (greater than 256 x 256). If users are not sure of the exam resolution being used, firm recommend contacting the hospital imaging department or local Medtronic Navigation representative for assistance. Medtronic representatives will visit all identified hospitals and upgrade all systems to version 5.4.1. This will account for all consignees.
Quantity in commerce: 572
Distribution: Worldwide Distribution.
Product codes and lots: Lot number(s): Not applicable; All kits containing the Framelink Software version 5.4 are affected by this corrective action.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1956-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1956-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-13

Product code HAW

K992927Class IIStealthstation Treatment Guidance PlatformSurgical Navigation Technologies, Inc. / cleared 1999-12-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)