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Pristina Via

by GE Medical Systems SCS France EUDAMEDGUDID

Ref 5993837Model MBE2

Product code MUEEMDN Z11030202

Regulatory status

as of 24 Oct 2026

Recall ongoing. 2 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00198953109281 UDI-DIDate1 Dec 2025ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number8406821BUG00205GY Basic UDI-DIDate12 May 2025RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

3 recalls · 2 ongoing · FDA

    • Ongoing Z-0875-2026 FDA Class II initiated 24 Oct 2025

    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).

    • Ongoing Z-0862-2024 FDA Class II initiated 26 Dec 2023

    X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.

    • Terminated Z-2131-2019 FDA Class II initiated 16 May 2019

    Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Trade Name
Pristina Via EUDAMED
Senographe Pristina GUDID
Generic Name
Stationary mammographic x-ray system, digital
Model / Reference
MBE2 EUDAMED
5993837 EUDAMED
POZ2 GUDID
Primary DI / UDI-DI
00198953109281
Basic UDI-DI
8406821BUG00205GY
Direct Marketing DI
00198953109281
PMA Number
510(k) Number
FDA Product Code
MUE, OTE
EMDN Code
Z11030202 Digital mammography systems
GMDN Term
Stationary mammographic x-ray system, digital
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.1715
Market of Registration
France
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MBE2
5993837
GUDID
POZ2
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
FR-MF-000000687

Other devices from GE Medical Systems SCS

See all devices from GE Medical Systems SCS →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Serial Number
  • Manufacturing Date
Other properties (21)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (2)

  • EUDAMED 89da93df-8113-48a0-a48c-de6239ddf4df 61 fields · synced 23 Oct 2026
  • FDA UDI a74fc81b-74c7-4da5-bf52-4d4b2cb9c1e9 35 fields · synced 23 Oct 2026