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Na 5789577

by GE Medical Systems, L.L.C. GUDID

Withdrawn United States

Regulatory status

as of 26 Oct 2026

Recall ongoing. 5 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840682135283 UDI-DIDate2 Nov 2017ListedStatusWithdrawn

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls

7 recalls · 5 ongoing · FDA

    • Ongoing Z-2309-2025 FDA Class II initiated 20 Jun 2025 via K163619, 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 K163619, 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 K163619, on the same 510(k)

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

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

Specification

GUDID

Trade Name
Na
Generic Name
PET system
Model / Reference
5789577
Primary DI / UDI-DI
00840682135283
510(k) Number
FDA Product Code
OUO
GMDN Term
PET system
Device Class
Class II
Regulation Number
892.1200
Commercial Distribution
Not in Commercial Distribution

Other devices from GE Medical Systems, L.L.C.

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Properties

Show properties
  • 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