Exact FDA event identifier

Event 75158

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

Open FDA event record

Event summary

Timeline bucket: November 01, 2012
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Merge Healthcare, Inc.

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

CADstream software. Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools.

Z-2871-2016

Recall number: Z-2871-2016
Initiated: November 01, 2012
Classification: Class II
Status: Terminated
Recalling firm: Merge Healthcare, Inc.
Quantity: 1,349 sites potentially have the affected versions

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

An incorrect biopsy or missed target could result if the incorrect grid is selected within the application.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An incorrect biopsy or missed target could result if the incorrect grid is selected within the application.

Code information

All versions - Versions 4.1.3 and prior versions

Distribution pattern

US Nationwide Distribution