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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70133

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

Open FDA event record

Event summary

Timeline bucket
November 12, 2014
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

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

The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.

Z-0955-2015
Recall number
Z-0955-2015
Initiated
November 12, 2014
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare
Quantity
13 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
quality control test was not performed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Radiation Control for Health and Safety Act

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A required quality control test was not performed during installation associated with the software of the Revolution CT scanner.

Code information

Software version: 14MW14.29

Distribution pattern

US Distribution to the states of CA, FL, IL, NY, UT and WA.