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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65743

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 15, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medtronic Navigation, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1956-2013
Recall number
Z-1956-2013
Initiated
July 15, 2013
Classification
Class II
Status
Terminated
Quantity
572

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software version 5.4 which can

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

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.