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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98081

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

Open FDA event record

Event summary

Timeline bucket
October 24, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
GE Medical Systems, 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

Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography

Z-0875-2026
Recall number
Z-0875-2026
Initiated
October 24, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
1,818 (1,580 US; 238 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j).

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

Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j).

Code information

GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026

Distribution pattern

U.S. and OUS.