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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68211

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

Open FDA event record

Event summary

Timeline bucket
April 30, 2014
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 CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.

Z-1662-2014
Recall number
Z-1662-2014
Initiated
April 30, 2014
Classification
Class II
Status
Terminated
Recalling firm
AGFA Corp.
Quantity
One

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.

Code information

Model L9M21000 - Software versions: IMPAX CV 7.8 SU3/SU4 - OCR Service

Distribution pattern

Distribution to SC only