Exact FDA event identifier

Event 62828

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

Open FDA event record

Event summary

Timeline bucket: November 01, 2010
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Canon 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

Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

Z-2265-2012

Recall number: Z-2265-2012
Initiated: November 01, 2010
Classification: Class II
Status: Terminated
Recalling firm: Canon Inc.
Quantity: 468 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.

Code information

Catalog numbers 3930B002AA, 3928B002AA, and 4066B002AA.

Distribution pattern

Nationwide Distribution (USA)