Exact FDA event identifier

Event 75279

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

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Event summary

Timeline bucket: September 22, 2016
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Medtronic Navigation, Inc.-Littleton

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

Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It provides real-time, intra-operative imaging of a patients anatomy with high quality images and a large field-of-view in both two and three dimensions

Z-0070-2017

Recall number: Z-0070-2017
Initiated: September 22, 2016
Classification: Class II
Status: Terminated
Recalling firm: Medtronic Navigation, Inc.-Littleton
Quantity: 14 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

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Inspect official wording and provenance

Reason for recall

O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images

Code information

Software revisions 4.0.0, 4.0.1 and 4.0.2. System Serial Numbers: C0930 C0981 C0986 C1113 C1069 C1050 C1208 C1043 C1144 C1163 C1145 C1162 C1002 C1074

Distribution pattern

Worldwide Distribution - US Nationwide in the states of CO, KA, NE, MI, MO, OH, WA and country of Switzerland