Exact FDA event identifier

Event 72472

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

Event summary

Timeline bucket: September 28, 2015
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: GE Healthcare

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

The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

Z-0225-2016

Recall number: Z-0225-2016
Initiated: September 28, 2015
Classification: Class II
Status: Terminated
Recalling firm: GE Healthcare
Quantity: Centricity PACS-IW with Universal Viewer Versions 5.0 SP2 and higher 1052 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Inaccurate distance measurements with magnified projection X-ray images.

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

Inaccurate distance measurements with magnified projection X-ray images.

Code information

2067131-001DVD UNIVERSAL VIEWER 5.0 - WEB CLIENT

Distribution pattern

Worldwide Distribution-US (nationwide) including the states of AZ, CA, CO, DE, FL, GA, IA, IL, IN, LA, MA, MI, MN, MO, NJ, NY, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV, and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Ecuador, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Japan, Kenya, Korea, Malta, Malaysia, Namibia, Netherlands, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, Taiwan, United Arab Emirates, United Kingdom and Venezuela.

device · product 2 of 2

The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

Z-0226-2016

Recall number: Z-0226-2016
Initiated: September 28, 2015
Classification: Class II
Status: Terminated
Recalling firm: GE Healthcare
Quantity: Centricity Universal Viewer versions 6.0 and higher 5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Inaccurate distance measurements with magnified projection X-ray images.

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

Inaccurate distance measurements with magnified projection X-ray images.

Code information

2088034-001 DVD UNIVERSAL VIEWER 6.0 - WEB CLIENT