Exact FDA event identifier

Event 62646

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

Open FDA event record

Event summary

Timeline bucket: July 27, 2012
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

IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)

Z-2184-2012

Recall number: Z-2184-2012
Initiated: July 27, 2012
Classification: Class II
Status: Terminated
Recalling firm: AGFA Corp.
Quantity: 280

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.

Code information

Model # L9M2100 - All Software versions of IMPAX CV Reporting

Distribution pattern

Worldwide Distribution - USA (nationwide) and Canada