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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64656

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

Open FDA event record

Event summary

Timeline bucket
March 15, 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

IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.

Z-1070-2013
Recall number
Z-1070-2013
Initiated
March 15, 2013
Classification
Class II
Status
Terminated
Recalling firm
AGFA Corp.
Quantity
26

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic health record (EHR) system.

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

Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic health record (EHR) system.

Code information

Model # L9M21000. Software versions: IMPAX CV 7.8, 7.8 SU1, 7.8 SU2 and 7.8 SU3, IMPAX CV 7.8 SU2.5 with IMPAX CV Outbound Report Stylesheet 7.8_HL

Distribution pattern

Nationwide Distribution including the states of AK, GA, IL, KY, MA, NY, NC, RI, SC, TX, and VA.