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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2025-10-24Z-0875-2026Class IIOpen, ClassifiedSome 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).Distribution: U.S. and OUS.1,818 (1,580 US; 238 OUS)clearance family
2023-12-26Z-0862-2024Class IIOpen, ClassifiedX-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.Distribution: Us Nationwide-Worldwide Distribution180 units (60 US; 120 OUS)clearance family
Regulatory clearances
  • 510(k)K211725Substantially equivalent (SESE) · 2021-08-06clearance family
  • 510(k)K211215Substantially equivalent (SESE) · 2021-06-22clearance family
  • 510(k)K193334Substantially equivalent (SESE) · 2020-05-15clearance family
  • 510(k)K182951Substantially equivalent (SESE) · 2019-01-18clearance family

Predicate lineage

Cited as predicate by: K163302, K172404, K173576, K193334, K211725

Cited as predicate by: K182951, K190809, K193334, K260087

Cited as predicate by: K260087

Cited as predicate by: K260087

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2022-09-29NAINo action indicatedGE Medical Systems, LLC0
2018-06-14VAIVoluntary action indicatedGE Medical Systems, LLC0
2016-10-11NAINo action indicatedGE MEDICAL SYSTEMS, LLC0
2014-11-10NAINo action indicatedGE Medical Systems, LLC0
2014-02-28VAIVoluntary action indicatedGE Medical Systems, LLC1
2013-06-17VAIVoluntary action indicatedGE Medical Systems, LLC1
2012-10-11NAINo action indicatedGE Medical Systems, LLC0
2012-03-02VAIVoluntary action indicatedGE Medical Systems, LLC7
2011-01-11VAIVoluntary action indicatedGE Medical Systems, LLC3
2010-04-26NAINo action indicatedGE Medical Systems, LLC0
2010-01-29NAINo action indicatedGE Medical Systems, LLC0
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