Exact FDA event identifier

Event 74522

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

Open FDA event record

Event summary

Timeline bucket: January 30, 2016
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

Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. OfficePACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. OrthoPACS also uses such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.

Z-2144-2016

Recall number: Z-2144-2016
Initiated: January 30, 2016
Classification: Class II
Status: Terminated
Recalling firm: Merge Healthcare, Inc.
Quantity: 216 sites have the affected software

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential data loss occurs as a result of the software archiving not working properly.

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

Potential data loss occurs as a result of the software archiving not working properly.

Code information

Software versions: 4.0, 4.1, 4.1.1, 4.1.2, and 4.2

Distribution pattern

The software was distributed nationwide to medical facilities. There was no government/military/foreign distribution.