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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68844

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

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Event summary

Timeline bucket
July 16, 2014
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
AGFA Healthcare 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

Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.

Z-2178-2014
Recall number
Z-2178-2014
Initiated
July 16, 2014
Classification
Class III
Status
Terminated
Recalling firm
AGFA Healthcare Corp.
Quantity
2617

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some sheets of the medical screen film are fogged.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some sheets of the medical screen film are fogged.

Code information

Lot Batch No. 79350052, 79380052, 79390074, 79400066, 79410063

Distribution pattern

Worldwide Distribution and US Nationwide in the states of AL, AZ, CA, FL, IL, LA, MI, MN, MS, NE, NH, NJ, NC and country of Canada