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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 61611

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

Open FDA event record

Event summary

Timeline bucket
May 24, 2012
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

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

AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.

Z-0754-2013
Recall number
Z-0754-2013
Initiated
May 24, 2012
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
65

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incorrectly labeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated.

Code information

Mfg Lot or Serial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

Distribution pattern

Worldwide Distribution - USA including AL, CT, FL, IL, MA, MO, NJ, NY, PA, TX VA, WA, WI and Internationally to TURKEY, TAIWAN, SWITZERLAND, SWEDEN, SOUTH AFRICA, NIGERIA, MALAYSIA, KOREA, JAPAN, INDIA, GERMANY, FRANCE, EGYPT, DENMARK, CHINA, CHILE, CANDA, BRAZIL, AUSTRIA, and GREAT BRITAIN.

Field note

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