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Signa Pet/Mr

by GE Medical Systems LLC United States EUDAMED510(k)GUDID

Ref SIGNA PET/MR Product code OUOEMDN Z11020701

Regulatory status

as of 26 Oct 2026

Recall ongoing. 5 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8406821BUG00307H9 Basic UDI-DIDate25 Jan 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00195278648877 UDI-DIDate19 Sep 2023ListedStatusIn distribution
United StatesFDA 510(k) 510(k) NumberK213709 Date20 Jan 2022IssuedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited 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 AmericaFranceFranceAustriaHungaryRomaniaUnited 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 AmericaFranceFranceSloveniaBulgariaUnited 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 AmericaPortugalSpainSpainItalyUnited 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 AmericaSpainSpainCroatiaGreeceUnited 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 AmericaMaltaCyprusUnited 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
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Certificates: none listed in EUDAMED

Recalls

8 recalls · 5 ongoing · FDA

    • Ongoing Z-2309-2025 FDA Class II initiated 20 Jun 2025 via K142098, on the same 510(k)

    GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

    • Ongoing Z-0520-2025 FDA Class II initiated 28 Oct 2024 via K142098, on the same 510(k)

    Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

    • Ongoing Z-2466-2024 FDA Class II initiated 14 Jun 2024

    GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

    • Ongoing Z-0595-2022 FDA Class II initiated 23 Dec 2021

    The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

    • Ongoing Z-2057-2021 FDA Class II initiated 4 Jun 2021

    GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

    • Terminated Z-0131-2021 FDA Class II initiated 8 Sep 2020

    Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

    • Terminated Z-3029-2017 FDA Class II initiated 11 May 2017 via K142098, on the same 510(k)

    Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

    • Terminated Z-0260-2016 FDA Class II initiated 31 Aug 2015

    When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

EUDAMED · 510(k) · GUDID · synced 23 Oct 2026

Trade Name
Signa Pet/Mr EUDAMED
Na GUDID
Generic Name
PET/MRI system
Model / Reference
SIGNA PET/MR EUDAMED
SIGNA PET MR GUDID
Primary DI / UDI-DI
00195278648877
Basic UDI-DI
8406821BUG00307H9
510(k) Number
FDA Product Code
OUO
EMDN Code
Z11020701 MRI/pet systems
GMDN Term
PET/MRI system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1200
Market of Registration
France
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
SIGNA PET/MR
GUDID
SIGNA PET MR
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000001632
Authorised representative
GE Medical Systems SCS FR-AR-000000344

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 (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 (3)

  • EUDAMED b8e2fcc0-782f-41c2-b58c-751d591a32df 61 fields · synced 23 Oct 2026
  • FDA UDI 79e9e54c-1e78-45f7-8f03-3b1f1f2bbc8d 34 fields · synced 29 May 2026
  • FDA 510(k) K213709 1 fields · synced 18 May 2026