Exact FDA event identifier

Event 83254

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

Open FDA event record

Event summary

Timeline bucket: January 19, 2019
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: GE Healthcare, LLC

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

Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

Z-1951-2019

Recall number: Z-1951-2019
Initiated: January 19, 2019
Classification: Class II
Status: Ongoing
Recalling firm: GE Healthcare, LLC
Quantity: 857 (US = 195: OUS = 662)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Additional low dose radiation exposure.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Additional low dose radiation exposure.

Code information

Revolution CT

Distribution pattern

Worldwide - US Nationwide Distribution