Skip to content

not applicable M3-2

by GE Medical Systems, LLC United States GUDID

Product code MUE

Regulatory status

as of 25 Oct 2026

Recall ongoing. 2 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840682125802 UDI-DIDate29 Sep 2017ListedStatusIn distribution

Coverage

1 jurisdiction

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 America
  • Listed
  • Not covered

United States — GUDID listing Listed

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

GUDID · synced 23 Oct 2026

Trade Name
not applicable
Generic Name
Stationary mammographic x-ray system, digital
Model / Reference
M3-2
Primary DI / UDI-DI
00840682125802
510(k) Number
FDA Product Code
MUE
GMDN Term
Stationary mammographic x-ray system, digital
Device Class
Class II
Regulation Number
892.1715
Commercial Distribution
In Commercial Distribution

Related devices

Category: Stationary mammographic x-ray system, digital

Cleared under the same submission (K162268)

Show all (12)

Cleared under the same submission (K172404)

Other devices from GE Medical Systems, LLC

See all devices from GE Medical Systems, LLC →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Serial Number
  • Manufacturing Date
Other properties (11)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: 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 (1)

  • FDA UDI 0fd0d249-ef6c-4d75-9744-c70ffc8aabf0 34 fields · synced 23 Oct 2026