Z-2466-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2024
- Initiation Date
- June 14, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 123 units
Product 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 for Recall
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.
Distribution Pattern
Worldwide distribution.
Code Information
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