Exact FDA event identifier

Event 64529

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

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Event summary

Timeline bucket: February 07, 2013
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: AGFA Corp.

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

CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used to capture images from X-Ray exposures. The cassette with the image plate, once exposed, is inserted in the Agfa Digitizer CR 10-X where the image plate is taken out of the cassette and then scanned so that the scanned image can be displayed for viewing.

Z-0970-2013

Recall number: Z-0970-2013
Initiated: February 07, 2013
Classification: Class II
Status: Terminated
Recalling firm: AGFA Corp.
Quantity: 17

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The cassettes were shipped with the wrong IP (image plate) size bar code.

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

The cassettes were shipped with the wrong IP (image plate) size bar code.

Code information

Batch No. A2KQMW

Distribution pattern

USA Nationwide Distribution including the states of: AL, CA, FL, IN, MN, NE, NV, OH, SC and UT.