510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-2466-2024Class II

SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager...

GE Healthcare / initiated 2024-06-14 / Open, Classified / root cause: design
FDA source (opens on fda.gov)

GE Medical Systems, LLC began a recall of 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... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number
Z-2466-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
GE Healthcare
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
Product code
OUO 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.
Root cause tag
design
FDA root cause
Device Design
Action
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.
Quantity in commerce
123 units
Distribution
Worldwide distribution.
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2466-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2459-2024Class IIOngoingVoluntary: Firm initiated
Z-2460-2024Class IIOngoingVoluntary: Firm initiated
Z-2461-2024Class IIOngoingVoluntary: Firm initiated
Z-2462-2024Class IIOngoingVoluntary: Firm initiated
Z-2463-2024Class IIOngoingVoluntary: Firm initiated
Z-2464-2024Class IIOngoingVoluntary: Firm initiated
Z-2465-2024Class IIOngoingVoluntary: Firm initiated
Z-2466-2024Class IIOngoingVoluntary: Firm initiated
Z-2467-2024Class IIOngoingVoluntary: Firm initiated
Z-2468-2024Class IIOngoingVoluntary: Firm initiated
Z-2469-2024Class IIOngoingVoluntary: Firm initiated
Z-2470-2024Class IIOngoingVoluntary: Firm initiated
Z-2471-2024Class IIOngoingVoluntary: Firm initiated
Z-2472-2024Class IIOngoingVoluntary: Firm initiated
Z-2473-2024Class IIOngoingVoluntary: Firm initiated
Z-2474-2024Class IIOngoingVoluntary: Firm initiated
Z-2475-2024Class IIOngoingVoluntary: Firm initiated
Z-2476-2024Class IIOngoingVoluntary: Firm initiated
Z-2477-2024Class IIOngoingVoluntary: Firm initiated
Z-2478-2024Class IIOngoingVoluntary: Firm initiated
Z-2479-2024Class IIOngoingVoluntary: Firm initiated
Z-2480-2024Class IIOngoingVoluntary: Firm initiated
Z-2481-2024Class IIOngoingVoluntary: Firm initiated
Z-2482-2024Class IIOngoingVoluntary: Firm initiated
Z-2483-2024Class IIOngoingVoluntary: Firm initiated
Z-2484-2024Class IIOngoingVoluntary: Firm initiated