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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83300

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 11, 2019
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

2 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 2

Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1

Z-2062-2019
Recall number
Z-2062-2019
Initiated
July 11, 2019
Classification
Class II
Status
Terminated
Recalling firm
Merge Healthcare, Inc.
Quantity
179 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).

Code information

Version 7.3 (UDI Number (01)00842000100690(10)7.3.0.158618(11)180409); 7.3.1 (UDI Number (01)00842000100690(10)7.3.1.161404(11)180830); 8.0 (UDI Number (01) 00842000100737 (10) 8.0.0.162051(11)181026); 8.0.1 (UDI Number (01) 00842000100737(10)8.0.1.165704(11)190528)

Distribution pattern

Nationwide distribution to Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Wisconsin. International distribution to Belgium and Canada.

device · product 2 of 2

Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1

Z-2063-2019
Recall number
Z-2063-2019
Initiated
July 11, 2019
Classification
Class II
Status
Terminated
Recalling firm
Merge Healthcare, Inc.
Quantity
73 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).

Code information

Version 7.3 (UDI Number (01)00842000100706(10)7.3.0.158618(11)180409); 7.3.1 (UDI Number (01)00842000100706(10)7.3.1.161404(11)180830); 8.0 (UDI Number (01)00842000100775(10)8.0.0.162051(11)181026); 8.0.1 (UDI Number (01)00842000100775(10)8.0.1.165704(11)190528)

Distribution pattern

Nationwide distribution to Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Wisconsin. International distribution to Belgium and Canada.