CLASS II ONGOING Device recall · Reported 14 Aug 2024 · FDA Enforcement Report

Signa Victor, with affected recalled by GE Medical Systems

GE Medical Systems is recalling Signa Victor, with affected. The recall was initiated on 14 Jun 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSystem ID: GON5374156, DZ4952MR01, MRPM1180, MRR8022, MRPM0474A, MRPM1267, MRR8322, MRPM0795, MRPM1093, FI1271MR01, XM9192701, MR53305381, 397480MR01, PC7479MR04, H6383MR02, MR00226, MR00207, 1553MR0071, PPS79502, SA2215MR01, GON5419122, GON5435507, 9761071
Quantity recalled23 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2480-2024
FDA event ID
94874
Recalling firm
GE Medical Systems, Waukesha, WI
Classification
Class II
Status
Ongoing
Recall initiated
14 Jun 2024
FDA classified
2 Aug 2024
Reported
14 Aug 2024
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Device Malfunction

Timeline

14 Jun 2024Recall initiated by company
2 Aug 2024Classified by FDA+49 days
14 Aug 2024Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System

Where it was distributed

Worldwide distribution.

Questions about this recall

Why was it 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.

Which lots are affected?

System ID: GON5374156, DZ4952MR01, MRPM1180, MRR8022, MRPM0474A, MRPM1267, MRR8322, MRPM0795, MRPM1093, FI1271MR01, XM9192701, MR53305381, 397480MR01, PC7479MR04, H6383MR02, MR00226, MR00207, 1553MR0071, PPS79502, SA2215MR01, GON5419122, GON5435507, 9761071

Where was it sold?

Worldwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

25 other products · FDA event 94874

This product is part of a recall event; the main page for the event is Signa Explorer, with affected recalled by GE Medical Systems.

ReportedClassRecallCompanyReasonWhere
CLASS IISigna Explorer, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI
CLASS IISigna Architect, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI
CLASS IISigna MR355, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI
CLASS IISigna PET/MR, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI
CLASS IIDiscovery MR450 1.5T, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI
CLASS IISigna Voyager, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI
CLASS IIOptima MR360, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI
CLASS IISigna UHP, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI
CLASS IISigna MR380, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI
CLASS IISigna MR360, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI
CLASS IIOptima MR450w 1.5T, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI
CLASS IISigna Creator, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI
CLASS IIDiscovery MR750 3.0T, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI
CLASS IISigna 7.0T, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI
CLASS II3.0T Signa HDxt Family, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI
CLASS IIDiscovery MR950, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI
CLASS IISigna Artist, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI
CLASS IISigna Hero, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI
CLASS IISigna Premier, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI
CLASS IISigna Magnus, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI
CLASS II1.5T Signa HDxt Family, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI
CLASS IISigna Prime, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI
CLASS IISigna Pioneer, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI
CLASS IIDiscovery MR750w 3.0T, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI
CLASS IIBrivo MR355, with affected recalled by GE Medical SystemsGE Medical SystemsDevice MalfunctionWI

More recalls from GE Medical Systems

All 160
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIOptima XR240amx, Mobile Digital Radiographic System recalledGE Medical SystemsDevice MalfunctionNationwide
DeviceCLASS IIOptima XR220amx, Mobile Digital-Ready Radiographic System recalledGE Medical SystemsDevice MalfunctionNationwide
DeviceCLASS IIOptima XR200amx, Mobile Digital-Ready Radiographic System recalledGE Medical SystemsDevice MalfunctionNationwide
DeviceCLASS IIGiraffe OmniBed Field Replaceable Unit (FRU) recalledGE Medical SystemsOtherNationwide
DeviceCLASS IIAllia IGS 7 Pulse angiographic X-ray system recalledGE Medical SystemsOtherNationwide

Other Imaging Equipment recalls

All 2,336
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIMedline Convenience Kits containing BD ChloraPrep Clear recalledMedline IndustriesPackaging DefectsNationwide
DeviceCLASS IIMedline Convenience Kits: Ultrasound Breast Pack recalledMedline IndustriesSterilityNationwide
DeviceCLASS IIAlphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalledCanon Medical System USAOtherNationwide
DeviceCLASS IIMerge PACS and Merge OrthoPACS recalled by Merge HealthcareMerge HealthcareLabeling ErrorsNationwide
DeviceCLASS IIPhilips Azurion recalled by Philips Medical SystemsPhilips Medical Systems NederlPotency & Assay