GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling SIGNA CREATOR and SIGNA EXPLORER diagnostic imaging devices due to an incorrect RF Power Monitor Function that could result in higher than expected thermal dose to patients and higher than expected localized heating. The recall affects 383 devices globally, including 24 devices in the United States located in Arizona, California, Connecticut, Florida, Illinois, Massachusetts, Mississippi, Missouri, North Carolina, Puerto Rico, Texas, and Wisconsin, with the remaining 359 devices distributed internationally across numerous countries.
No failures of this type have been reported, and no injuries have resulted from this issue. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could result in higher than expected thermal dose to the patient and higher than expected localized heating. There have been no failures of this type reported, and no injuries reported as a result of this issue.
Reason for recall: GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could result in higher than expected thermal dose to the patient and higher than expected localized heating. There have been no failures of this type reported, and no injuries reported as a result of this issue. Distribution: US: AZ, CA, CT, FL, IL, MA, MS, MO, NC, PR, TX, WI. OUS: Algeria, Australia, Bangladesh, Belgium, Brazil, Canada, Colombia, Dominican republic, Egypt, France, Germany, Ghana, Guatemala, HONG KONG, Hungary, India, Indonesia, Iran, Italy, Jamaica, Japan, Korea, Kuwait, LEBANON, Lithuania, Maldives, Martinique, Mexico, MOROCCO, Netherlands, New Zealand, OMAN, Pakistan, Philippines, Poland, Portugal, Quantity: 383 (US = 24;OUS = 359) Lot/code info: Mfg Lot or Serial # System ID MNEXP1600002MR 480425MR7 001709TA5 520ASRMR 003175TA7 916RAFMR 002448TA9 559449SPMR 002674TA0 559449SPMR 002027TA1 203337MREXP 003012TA2 GON: 4371049 002974TA4 239458MR1 003399TA3 239292MR1 002380TA4 305983MR3 002753TA2 727869MR 003356TA3 954473MR1 003176TA5 773843SCMR 000753TA4 574206MR 003013TA0 508746JMR2 003019TA7 417269MRS2 003371TA2 601853MR1 001027TA2 704384MINT 001059TA5 7 04384MINT 002453TA9 513569MR1 002741TA7 513584MR 001063TA7 254965CTOMR1 002879TA5 920560EXP 002831TA6 GON: 1532602 002023TA0 DZ1035MR03 002081TA8 DZ1863MR01 003302TA7 GON: 4399202 002742TA5 GON: 4374136 003076TA7 DZ1149MR02 003731TA7 DZ2014MR01 003079TA1 DZ1908MR01 003078TA3 DZ1174MR01 003565TA9 GON: 4345190 003134TA4 DZ1947MR01 002883TA7 83147183761 003174TA0 83140192745 003508TA9 83151589682 003403TA3 083027600486516 001232TA8 190073MR02 003439TA7 2626380 003441TA3 MRR10842 002687TA2 MRR10744 003440TA5 MRR10833 002090TA9 MRR10671 003793TA7 GON: 4393875 002949TA6 604988MRI 002219TA4 MRR10679 003212TA8 MRR10843 002876TA1 MRR10762 003177TA3 MRR10799 003754TA9 MRR10892 003359TA7 MRR5954 002885TA2 EG1826MR02 002450TA5 EG1990MR01 002886TA0 EG2266MR01 001502TA4 EG1112MR02 003213TA6 EG1709MR01 003083TA3 EG1522MR01 003133TA6 EG1237MR01 003354TA8 EG1505MR02 002446TA3 EG1196MR01 002940TA5 EG1998MR01 002743TA3 EG1245MR03 003267TA2 EG1069MR02 003172TA4 GP1022MR02 001405TA0 X227040904 001124TA7 A1039630 001231TA0 X2881410 000898TA7 M4174549 001307TA8 M23084330 003307TA6 M1265006 00
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.