GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . 의 리콜

Mfg Lot or Serial # 00000029854MR5 00000288907MR9 00000289309MR7 00000289310MR5 00000289961MR5 00000290050MR4 00000290137MR9 00000290202MR1 00000290457MR1 00000290502MR4 00000290659MR2 00000290773MR1 00000290957MR0 00000291185MR7 00000291325MR9 00000291363MR0 00000291397MR8 00000291464MR6 00000291489MR3 00000292367MR0 00000292471MR0 00000292528MR7 00000292634MR3 00000292843MR0 00000293065MR9 00000293874MR4 00000294098MR9 00000294398MR3 00000294472MR6 00000294556MR6 00000294576MR4 00000294718MR2 00000295111MR9 00000295134MR1 00000295215MR8 00000296070MR6 00000296097MR9 00000296171MR2 00000296226MR0 00000296228MR0 00000296300MR7 00000296369MR2 00000296429MR4 00000296462MR5 00000296469MR0 00000296626MR5 00000296829MR5 00000296840MR2 00000296841MR0 00000296860MR0 00000297134MR9 00000297147MR1 00000297355MR0 00000297387MR3 00000297493MR9 00000297833MR6 00000297880MR7 00000297891MR4 00000298050MR6 00000298114MR0 00000298247MR8 00000298248MR6 00000298249MR4 00000298310MR4 00000298386MR4 00000298387MR2 00000298494MR6 00000298512MR5 00000298535MR6 00000298552MR1 00000298573MR7 00000298574MR5 00000298655MR2 00000298656MR0 00000298675MR0 00000298722MR0 00000298727MR9 00000298834MR3 00000298836MR8 00000298861MR6 00000298869MR9 00000298870MR7 00000298889MR7 00000298901MR0 00000298932MR5 00000298943MR2 00000298959MR8 00000299141MR2 00000299160MR2 00000299161MR0 00000299171MR9 00000299172MR7 00000299173MR5 00000299199MR0 00000299200MR6 00000299230MR3 00000299264MR2 00000299294MR9 00000299320MR2 00000299339MR2 00000299411MR9 00000299491MR1 00000299503MR3 00000299522MR3 00000299559MR5 00000299560MR3 00000299627MR0 00000299634MR6 00000299645MR2 00000299647MR8 00000299683MR3 00000299823MR5 00000299851MR6 00000299952MR2 00000300038MR7 00000300039MR5 00000300122MR9 00000300296MR1 00000300473MR6 00000300493MR4 00000300494MR2 00000300564MR2 00000300565MR9 00000300571MR7 00000300572MR5 00000300588MR1 00000300590MR7 00000300883MR6 00000300906MR5 00000300929MR7 00000300967MR7 00000300985MR9 00000301126MR9 00000301292MR9 00000301401MR6 00000301471MR9 00000302248MR0 00000302515MR2 00000302688MR7 00000302690MR3 00000302945MR1 00000303050MR9 00000303637MR3 00000304836MR0 00000304943MR4 00000305101MR8 00000305102MR6 00000305165MR3 00000305203MR2 00000305412MR9 00000305426MR9 00000305453MR3 00000305464MR0 00000305519MR1 00000305521MR7 00000305524MR1 00000306011MR8 00000306028MR2 000005148810-3 00000815BD3A44 00000837BD4DEA 00000837BD4E30 00000849BD53AB 00000849BD53A3 00000903BD55F2 00000913BD5A64 00000914BD5A84 00000918BD5B2E 00000918BD5B4E 00000919BD5BB2 00000919BD5B96 00000919BD5B99 00000926BD5CF6 00000931BD5D7E 00000933BD5E45 00000937BD5EF9 00000944BD6152 00000944BD6158 00000944BD6166 00000944BD6170 00000944BD6172 00000945BD617D 00000945BD617F 00000945BD6185 00000950BD62A5 00000950BD627E 00000950BD6283 00000952BD62E6 00001001BD6325 00001002BD63F2 00001002BD6371 00001002BD638E 00001002BD6393 00001003BD63F7 00001004BD643D 00001006XF510D 00001007BD6473 00001007BD648C 00001007BD6481 00001007BD6493 00001009BD65B4 00001009BD654B 00001009BD656E 00001009BD659D 00001009BD6591 00001009BD6593 00001010BD660A 00001011BD661D 00001011BD6630 00001011BD664A 00001011BD6658 00001012BD66A9 00001012BD66B6 00001012BD66CE 00001012BD66F2 00001018XF5027 00001018XF503B 00001018XF5039 00001026XF5154 00001026XF5155 00001026XF5173 00001026XF5175 00001026XF5178 00001026XF5191 00001027XF500C 00001027XF5004 00001027XF5018 00001046XF5004 00001048XF5028 00001049XF500C 00001049XF500F 00001049XF5004 00001049XF5005 00001049XF5007 00001049XF5008 00001049XF501A 00001049XF5011 00001049XF5014 00001049XF5019 00001050XF5015 00001050XF5017 00001050XF5020 00001050XF5024 00001051XF5039 00001052XF5031 00001052XF5053 00001052XF5096 00001101XF50AA 00001101XF50AD 00001101XF50BC 00001101XF50B0 00001101XF50B2 00001101XF50B6 00001101XF50B7 00001101XF50B8 00001101XF50C0 00001101XF502E 00001101XF502F 00001101XF5023 00001101XF503A 00001101XF503E 00001101XF5030 00001101XF504B 00001101XF5046 00001101XF5047 00001101XF505B 00001101XF5054 00001101XF5056 00001101XF5058 00001101XF5059 00001101XF5066 00001101XF507A 00001101XF507D 00001101XF5075 00001101XF5076 00001101XF5077 00001101XF5078 00001101XF508C 00001101XF508E 00001101XF5081 00001102XF50A2 00001102XF500A 00001102XF500F 00001102XF5003 00001102XF501B 00001102XF501D 00001102XF5019 00001102XF502C 00001102XF502F 00001102XF5022 00001102XF5023 00001102XF5025 00001102XF5029 00001102XF504D 00001102XF5046 00001102XF5072 00001102XF5073 00001102XF5074 00001102XF5076 00001104XF5022 00001105XF502C 00001105XF503D 00001105XF503E 00001105XF504A 00001105XF504D 00001105XF5044 00001105XF5046 00001106XF50CB 00001106XF50CC 00001106XF50C0 00001106XF50D1 00001106XF50EF 00001106XF50F2 00001106XF50F3 00001106XF50F7 00001106XF500A 00001106XF500B 00001106XF500C 00001106XF500F 00001106XF5001 00001106XF5003 00001106XF5009 00001106XF501B 00001106XF501D 00001106XF5010 00001106XF5014 00001106XF5016 00001106XF5019 00001106XF5020 00001106XF5024 00001106XF5028 00001106XF503C 00001106XF503F 00001106XF5033 00001106XF5034 00001106XF5048 00001106XF5074 00001106XF509C 00001106XF5097 00001106XF512C 00001106XF5131 00001111FMM0B5 00001111FMM0B6 00001117FMM0CG 00001117FMM0CW 00001117FMM0C2 00001117FMM0C8 00001118FMM0WD 00001118FMM0WG 00001118FMM0WL 00001118FMM0WN 00001134FMM10M 00001134FMM103 00001134FMM105 00001134FMM108 00001139FMM0DA 00001140FMM0FN 00001140FMM0FW 00001140FMM0G5 00001142FMM08W 00001147FMM0E9 00001201FMM08B 00001203FMMOUJ 00001203FMMOUV 00001203FMM0UL 00001203FMM0UU 00001203FMM0UY 00001203FMM0VF 00001203FMM0VJ 00001203FMM0VL 00001203FMM0VR 00001203FMM0VU 00001203FMM0V0 00001203FMM0V3 00001204FMM04F 00001204FMM04K 00001204FMM04N 00001204FMM04W 00001204FMM04X 00001204FMM046 00001204FMM047 00001204FMM05B 00001204FMM05D 00001204FMM056 00001204FMM059 00001213FMM0LE 00001213FMM0LF 00001213FMM0LG 00001213FMM0LV 00001219FMM0GJ 00001219FMM0GT 00001220FMM01D 00001220FMM01K 00001221FMM06U 00001221FMM184 00001223FMM08L 00001227FMM00B 00001227FMM00D 00001227FMM00G 00001227FMM00L 00001232FMM01N 00001232FMM01P 00001232FMM01R 00001232FMM01U 00001233FMM06J 00001233FMM06T 00001233FMM078 00001234FMM0KE 00001234FMM0K0 00001234FMM0K1 00001234FMM0K5 00001236FMM00R 00001236FMM00V 00001236FMM01B 00001236FMM01F 00001236FMM01M 00001236FMM01V 00001236FMM01W 00001236FMM010 00001236FMM011 00001245FMM02B 00001245FMM03P 00001250FMM01V 00001250FMM02D 00001250FMM02T 00001250FMM021 00001250FMM029 00001250FMM04P 00001250FMM052 00001251FMM00N 00001251FMM00Y 00001251FMM01B 00001251FMM01K 00001251FMM01N 00001251FMM01V 00001251FMM01Y 00001251FMM010 00001251FMM018 00001251FMM020 00001251FMM022 00001251FMM028 00001251FMM03A 0000212825A73E 00000291429MR9 00000914BD5A87 00001007BD6466 00001011BD633E 00001101XF50BB 00001102XF509F 00001106XF50E8 00001106XF50FF 00001117FMM0C7 00001203FMM0W0 00001204FMM044 00001236FMM012 00000299229MR5 00000300587MR3 00001106XF5036 00000931BD5D86 00000295060MR8 00000297156MR2 00000298473MR0 00000299824MR3 00000300472MR8 00000300474MR4 00000300586MR5 00000302203MR5 00000304438MR5 00001003BD643A 00001012BD66AE 00001048XF5027 00001101XF507C 00001102XF501A 00001102XF5010 00001106XF5017 00001204FMM04J 00000030090MR1 00000291008MR1 00000291154MR3 00000304945MR9 00000305413MR7 00000944BD616B 00000944BD6160 00001009BD65BF 00001009BD659C 00001012BD66AA 00001012BD66B9 00001012BD66C7 00001101XF501B 00001101XF501F 00001101XF502C 00001101XF5028 00001101XF503C 00001101XF505A 00001106XF50BA 00001106XF512E 00001147FMM0EA 00001203FMM0VA 00001204FMM051 00001219FMM0GW 00001227FMM00Y 00001245FMM03U 00001251FMM01M 00001251FMM01R 00001009BD659E 00000298116MR5 00000301927MR0 00001009BD65AC 00001009BD65A1 00001012BD6696 00001026XF518E 00001044XF5030 00001048XF500F 00001101XF5016 00001101XF5019 00001101XF5022 00001101XF5027 00001101XF5033 00001101XF5035 00001105XF502F 00001106XF50B4 00001106XF50C3 00001106XF50C5 00001106XF50DF 00001106XF50D0 00001106XF50D7 00001106XF502D 00001106XF504D 00001106XF5042 00001106XF5043 00001106XF5055 00001106XF506B 00001106XF507A 00001106XF508E 00001106XF5090 00001106XF512A 00001106XF5125 00001049XF5018 00000305405MR3 00001004BD6449 00001009BD65EC 00000934BD5E49 00001203FMM0VE 00000296291MR8 00000952BD62F0 00000294713MR3 00000295485MR7 00000298431MR8 00000299453MR1 00000845BD51B5 00001117FMM0CX 00001221FMM06P 00000290985MR1 00000292928MR9 00000296879MR0 00000297164MR6 00000297468MR1 00000297715MR5 00000298073MR8 00000298242MR9 00000298385MR6 00000298430MR0 00000298567MR9 00000298850MR9 00000299341MR8 00000300589MR9 00000302711MR7 00000903BD55F9 00000914BD5A8C 00000919BD5B80 00000936BD5E6F 00000952BD62E5 00001001BD6337 00001002BD639D 00001002BD6397 00001003BD6400 00001007BD6497 00001009BD6552 00001009BD658D 00001027XF500B 00001044XF502E 00001105XF502B 00001105XF503C 00001105XF5031 00001106XF50F9 00001106XF5064 00001106XF5114 00001111FMM0B1 00001111FMM0B3 00001111FMM0B4 00001111FMM0MX 00001111FMM0N7 00001118FMM0WB 00001118FMM0WH 00001134FMM106 00001139FMM0D5 00001140FMM0FD 00001140FMM0FV 00001140FMM0G3 00001203FMM0UH 00001203FMM0VC 00001203FMM0V1 00001204FMM04M 00001204FMM049 00001219FMM0GK 00001219FMM0GP 00001236FMM01C 00001251FMM01T 00001251FMM019 00002996333MR8 00000288156MR3 00000296406MR2 00000298676MR8 00000299261MR8 00000301824MR9 00000842BD50C3 00000914BD5A86 00000918BD5B4C 00001102XF5054 00001112FMM080 00001117FMM0CB 00001117FMM0CP 00001118FMM0WT 00001140FMM0FE 00001236FMM01L 00000293710MR0 00001009BD656B 00000300763MR0 00000300561MR8 00000301544MR3 00000304074MR8 00000915BD5AEF 00000291778MR9 00000296834MR5 00000939BD5F75 00001117FMM0CT 00000291345MR7 00000294545MR9 00000905BD567C 00000934BD5E44 00000952BD62F9 00001007BD6483 00001009BD65E3 00001026XF5151 00001027XF5006 00001044XF5032 00001101XF5073 00001106XF50AE 00001106XF50BF 00001106XF501A 00001106XF5120 00001118FMM0WP 00001204FMM04H 00001213FMM0LW 00000295180MR4 00000298566MR1 00000299147MR9 00000299293MR1 00000299455MR6 00000300734MR1 00000301194MR7 00000950BD627F 00001007BD6477 00001026XF516F 00001026XF5176 00001027XF501B 00001027XF5017 00001101XF5020 00001106XF50A5 00001106XF502A 00001106XF503E 00001106XF504C 00001106XF506C 00001106XF5068 00001106XF507C 00001106XF5094 00001106XF5134 00001117FMM0C6 00001118FMM0WK 00001118FMM0W9 00001134FMM10G 00001134FMM10N 00001140FMM0FK 00001203FMM0UX 00001203FMM0VD 00001219FMM0H0 00001221FMM06N 00001227FMM010 00001227FMM013 00000297007MR7 00000298272MR6 00000298331MR0 00000299419MR2 00000300733MR3 00001018XF5029 00001026XF515A 00001101XF5039 00001101XF506C 00001102XF509B 00001106XF5004 00001106XF503D 00000298211MR4 00001044XF5035 00001118FMM0W7 00001236FMM01Y 00001102XF50A4 00001102XF5036 00000299521MR5 00000301495MR8 00000926BD5D00 00001105XF5049 00000292216MR9 00000304910MR3 00001111FMM0N2 00001203FMM0W1 00001227FMM00H 00000288409MR6 00000952BD62FD 00001018XF501A 00001204FMM05H 00001106XF5121 00000296622MR4 00000303814MR8 00001002BD63F5 00001105XF5047 00001233FMM06H 00001236FMM01T 00000300865MR3 00001007BD6471 00001049XF5012 00001101XF5053 00001101XF5070 00001102XF5027 00001105XF504C 00001106XF502F 00001147FMM0EG 00001204FMM05E 00001233FMM06U 00001234FMM0KK 00000296613MR3 00000298266MR8 00000299951MR4 00000919BD5B81 00001101XF501C 00001203FMM0UN 00001219FMM0GN 00001251FMM00P 00001102XF5032 00001134FMM107 00000299140MR4 00000297154MR7 00000299452MR3 00001102XF5002 00001102XF5030 00001118FMM0WV 00001118FMM0W6 00001236FMM00K 00000295710MR8 00000304828MR7 00000848BD5326 00000919BD5B88 00000952BD62E8 00001007BD6494 00001011BD6689 00001106XF505A 00001140FMM0G1 00001204FMM04C 00001204FMM04T 00001233FMM06R 00000297386MR5 00000297422MR8 00000298944MR0 00000836BD4DDD 00001009D6547B 00001026XF516D 00001106XF5076 00001111FMM0N6 00001118FMM0WU 00001223FMM08N 00000931BD5D88 00000944BD6163 00001009BD65E7 00001011BD662B 00001101XF5025 00001101XF5037 00001106XF5035 00001106XF5052 00001106XF5078 00001106XF5080 00001227FMM00P 00001251FMM026 00001105XF5033 00001106XF5051 00001101XF5091 00000290456MR3 00000290545MR3 00000291274MR9 00000293724MR1 00000296321MR3 00000297132MR3 00000298493MR8 00000298501MR8 00000301296MR0 00000302675MR4 00000304078MR9 00000903BD55D2 00000913BD5A63 00000931BD5D89 00000944BD6169 00000950BD62C1 00001007BD6476 00001011BD6624 00001011BD6639 00001012BD66CA 00001026XF5170 00001102XF50A9 00001105XF502A 00001106XF5002 00001106XF5007 00001106XF501E 00001106XF507F 00001117FMM0CJ 00001117FMM0CR 00001117FMM0CV 00001118FMM0W4 00001147FMM0E7 00001203FMM0VT 00001026XF5196

Radiology Devices

2

No

Worldwide Distribution USA including DC, all states except HI, ND, RI and WY and Internationally to Australia, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Korea (Republic of), Kuwait, Lebanon, Martinique, Mexico, Netherlands, New Zealand, Norway, Oman, Poland, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, . OUS: AUSTRALIA, AUSTRIA, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, MARTINIQUE, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, QATAR, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY.

GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . || scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa¿ MR 750 System is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and organs of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the GE Signa¿ MR 750 System reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images when interpreted by a trained physician yield information that may assist in diagnosis. The indications for use for the 3.0T GE Signa¿ MR750 System are similar to those for the Signa¿ HDx Magnetic Resonance System and the Siemens MAGNETOM Verio MR System. K113490: The Optima" MR450w is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being images, contrast agents may be used. The images produced by the Optima" MR 450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. K083147: The Discovery MR 450 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images spectroscopic images parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR450 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.