Exact FDA event identifier

Event 92516

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

Open FDA event record

Event summary

Timeline bucket: May 09, 2023
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Virtual Radiologic 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

vRad PACS with Mammography

Z-2235-2023

Recall number: Z-2235-2023
Initiated: May 09, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Virtual Radiologic Corp.
Quantity: 8 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist.

Code information

(01)00862234000313(10)23.2 Build 23.2.0.117 through (01)00862234000313(10) 23.4 Build 23.4.25.1

Distribution pattern

US Nationwide distribution in the states of MD, MN, TN, FL, GA, TX, OK.