Exact FDA event identifier

Event 97045

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

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Event summary

Timeline bucket: May 27, 2025
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Medtronic Navigation, Inc.-Boxborough

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

O-arm O2 Imaging System. Mobile X-Ray System.

Z-2101-2025

Recall number: Z-2101-2025
Initiated: May 27, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Medtronic Navigation, Inc.-Boxborough
Quantity: 3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.

Code information

CFN: BI70002000; UDI: 00763000709631; Serial No. C4014, C4017, C4019.

Distribution pattern

US Nationwide distribution in the states of IN, MN, MS.