BEUDAMED
    FDA Enforcement Class II Ongoing

    SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emission computed tomography with nuclear magnetic resonance

    Recall: Z-2466-2024 · Reported August 14, 2024

    Enforcement

    Recall Number
    Z-2466-2024
    Event ID
    94874
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Medical Systems, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 14, 2024
    Initiation Date
    June 14, 2024
    Classification Date
    August 2, 2024
    Address
    3200 N Grandview Blvd, Waukesha, WI, 53188-1693, United States

    Description

    SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emission computed tomography with nuclear magnetic resonance

    Reason

    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.

    Code Info

    System ID: UABMRPET, 480342PETMR1, 415493VMR4, 415723CHMR6, 415CBMRPWS, 415CBMRP, 415723SHMR15, 415723SHWS15, 415723SHMRW, 720482PETMR, DUPONTPETMR, 904953PMR3T, 404778PETMR, 617726PETMR, 301496PETMR, MAYOPETMR01, WCIDHKMR1, MSK68MR01, 914681MR3T, 503418PETMR, 503418PETMRSPIC, CHOPPETMR, 713792AMR19, 608262PETMR1, 414266PETMR1, DZ4291MR01, MR7949AR, MRUA0459, 210002MR01, 030130MR01, MRUA0479, 604822MRP1, 082427040215, 082427130107, 082427250097, 082427210164, 082427030119, 082427100282, 082427190178, 082427160323, 082427170035, 082427120212, 082427120313, 082427020118, 082427220136, 082427030216, 082427040292, 082427040280, 082427040207, 082427110082, 082427140224, 082427030160, 082427220094, 082427170048, 082427070262, 082427090310, 082427220114, 082427220112, 082427140163, 082427140138, 082427130192, 082427130193, 082427130194, 082427130195, 082427130180, 082427040222, 082427040235, 082427020108, 082427230116, 082427110117, 082427160373, 082427150088, 082427120373, 082427120381, 082427070319, 082427140168, 082427150134, 082427150124, 082427220079, 082427310151, CS1013MR01, DK1054PT24, DK1047MR07, EG2676MR01, FI1149MR02, FI1003MR03, MR51694181, A4493006, M40345211, M883443911, 083027609080621, IL1028MR07, A51299125, A51043290, EX0135, EX0133, EX0132, EX0134, EX0131, EX0130, KW1013MR09, KW1008MR03, MR52664941, RTD3120, RU8438MR04, MPX57802, ME5043181, NPD08400, O005MR02, AC001MR02, C001MR01, A210MR01, 120810MR03, 0853270166, 0853270188, 34452MRS01, 06002MRS05, 06008MRS03, 00133PMR01, 10311PMR01, 10732PMR01, 10728PMR01, 11080PMR01

    Distribution

    Worldwide distribution.

    Quantity

    123 units