Exact FDA event identifier

Event 86932

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

Event summary

Timeline bucket: November 23, 2020
Product types: Device
Classifications: Class II
Statuses: Terminated
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

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

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

Z-0694-2021

Recall number: Z-0694-2021
Initiated: November 23, 2020
Classification: Class II
Status: Terminated
Recalling firm: GE Healthcare, LLC
Quantity: 2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software in the Use Environment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling

Code information

Model Number: 5995001-6; Serial Number's: REVV81900024CN (System ID:561955REV/UDI: 01008406821234711119070021REVV81900024CN) and REVV81900022CN (System ID: DPN80000/ UDI:01008406821234711119070021REVV81900022CN).

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of FL and TX. The countries of Belgium, France, and Spain.

device · product 2 of 2

Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

Z-0695-2021

Recall number: Z-0695-2021
Initiated: November 23, 2020
Classification: Class II
Status: Terminated
Recalling firm: GE Healthcare, LLC
Quantity: 3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software in the Use Environment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling

Code information

Model Number: 5995000-5; Serial Number's: REVVX1700078CN (System ID: 713MMREVCT/UDI: 01008406821185521117070021REVVX1700078CN) , 00000440315CN0 (System ID: 220078CT04), and REVVX1800040CN (System ID: M2322265/UDI: 01008406821185521118030021REVVX1800040CN).

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of FL and TX. The countries of Belgium, France, and Spain.