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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86932

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

Open FDA event record

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.