GE Medical Systems, LLC: 73 recalls on record

Recalls filed with 1 agency: FDA (73).

First recall on record: November 11, 2015. Most recent: July 22, 2026.

Risk classification: Class II: 73

Most recent recalls

DateAgencyProduct
August 14, 2024FDA3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.…Z-2463-2024
August 14, 2024FDASIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance…Z-2474-2024
August 14, 2024FDASIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX26.1, PX28.0…Z-2460-2024
August 14, 2024FDASIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; T…Z-2466-2024
August 14, 2024FDADiscovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to…Z-2464-2024
August 14, 2024FDASIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2…Z-2470-2024
August 14, 2024FDADiscovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 t…Z-2465-2024
August 14, 2024FDAOptima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear M…Z-2478-2024
August 14, 2024FDASIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Re…Z-2461-2024
December 28, 2022FDAVivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Ab…Z-0753-2023
August 23, 2017FDA1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The 1.5T S…Z-3028-2017
August 23, 2017FDAOptima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole bo…Z-3022-2017
August 23, 2017FDAOptima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system is a whole body magne…Z-3024-2017
August 23, 2017FDASIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGNA Explorer i…Z-3026-2017
August 23, 2017FDA1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibran…Z-3027-2017
August 23, 2017FDAOptima MR750 3.0T Product Usage: The Optima MR450 1.5T system is a whole body magnet…Z-3023-2017
April 13, 2016FDASIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer is a whole body magnetic re…Z-1347-2016
March 16, 2016FDALightSpeed QX/I (4-slice MDAS) LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 C…Z-1053-2016
March 16, 2016FDADiscovery LS, 2286327 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner…Z-1049-2016
March 16, 2016FDADiscovery ST, , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner…Z-1050-2016
February 17, 2016FDAGE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to …Z-0768-2016
December 23, 2015FDAGE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray systems are indic…Z-0414-2016
November 11, 2015FDAMR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-20…Z-0196-2016

Questions about this company

How many recalls does GE Medical Systems, LLC have?
Recalert has 73 U.S. recalls on record for GE Medical Systems, LLC, published between November 11, 2015 and July 22, 2026.
Which agencies have handled GE Medical Systems, LLC recalls?
GE Medical Systems, LLC appears as the recalling firm in recalls from: FDA (73).

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