—#208535

Product

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

FDA product code: OUO — Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K142098, K163619, K213709
Affected lot / 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

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

GE Healthcare issue an URGENT MEDICAL DEVICE CORRECTION to its consignees via letter on 06/14/2024. The letter explained the problem with the device, safety issue, and requested the following: "Actions to be taken by Customer/User: You can continue to use your MR system by following the instructions below: To ensure that the displayed B1+RMS value on the Scan Prescription User Interface does not exceed the user prescribed limit specified in the Low SAR Mode User Interface: " If your software version includes the Optimized T2 FLAIR Sequence option, enable this option by setting the value to 1.00. This option is present on the Advanced Tab of the Scan Prescription User Interface. " If your software version does not include the Optimized T2 FLAIR Sequence option, adjust scan parameters such as TR , # Slices or Auto Refocus Flip Angle until the displayed B1+RMS value on the Scan Prescription User Interface does not exceed the user prescribed limit. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

Recalling firm

Firm: GE Medical Systems, LLC
Address: 3200 N Grandview Blvd, Waukesha, Wisconsin 53188-1693

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2024-06-14
Posted by FDA: 2024-08-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208535. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.