GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2. GE Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T. The 1.5T Signa HDx family and 3.0T Signa HDx family are 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

Recall details

Manufacturer

GE Healthcare, LLC

Distributor

Worldwide Distribution - All states in continental USA including DC except AK, AZ, RI and WY. and the countries of : AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEANON, MARINIQUE, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE,SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, LUXEMBOURG, PORTUGAL, VIETNAM and URUGUAY.

Lot

REF 60850 Mfg Lot or Serial # 00000204882MR5 00000233303MR7 00000241103MR1 00000245171MR4 00000247204MR1 00000173038MR1 00000136104MR7 00000264553MR9 00000265096MR8 00000005532YR7 00000007097YR9 00000007556YR4 00000281841MR7 00000289583MR7 0000SGH919066P 00000013883YR4 0000SGH231PPQK 00002UA2050JKX 00002UA2400LWP 00002UA24315PT 00002UA24315PY 00002UA24315P5 00002UA24907W7 00000266797MRO 00000267189MR0 00000270550MR7 00000283466MR1 00000305180MR2 00000306054MR8 0000267533MR8A Not Available 00000237000MR5 00000226580MR9 00000230105MR9 00000285956MR9 00000305386MR5 00000012562YR5 Not Available 000002UA4907WH 00002UA2400LWZ 00000177845MR5 00000165805MR3 00000836BD4DE2 00000012383YR6 00000269416MR4 Not Available 00002UA2400LWN 00000284254MR0 00000287469MR1 00000304797MR4 00002UA24907WK 00000005220YR9 00002UA2420VVZ 00002UA24907YC 00002UA24907YD 00002UA2510YTL 00000287996MR3 00000934BD5E4F 00000005966YR7 00000919BD5B8F 00000285151MR7 00000275969MR4 00000286019MR5 00000288669MR5 00001008BD6522 00000PH150024A 00000280423MR5 00000283613MR8 00000288416MR1 00000289840MR1 00000291157MR6 00000297685MR0 00000012064YR2 00000012526YR0 00000013660YR6 00000013820YR6 00000015654YR7 00001052XF502C 00001052XF5068 00001105XF5017 0000SGH048S36G 0000SGH105P174 0000SGH150RLYV 0000SGH150RLYX 0000SGH201TZ0V 0000SGH203QRPF 00002UA2050JKD 00002UA2050JL0 00002UA2070RGR 00002UA211170R 00002UA2281GGK 00002UA2281GGL 00002UA22827QF 00002UA2321LKW 00002UA2400LWJ 00002UA2400LWW 00002UA24907WJ 00000026639MR2 00000276261MR5 00000246260MR4 00000273065MR3 00000011594YR9 00000013110YR2 00001048XF5001 0000SGH106PMD7 814 00002UA2050JK7 00002UA2050JL2 00002UA2201G10 00002UA2201G19 00002UA22912Y5 00000264642MR0 00000305822MR9 00000265606MR4 Not Available 00000304307MR2 00000013981YR6 00002UA2400LX2 00000213294MR2 809 811 00000273256MR8 00000221025MR0 00000174670MR0 00000259576MR7 00000288072MR2 00000298886MR3 00000304463MR3 00000002761M65 00000002763M61 00000002766M64 00000003066M68 00000012720M69 00000012955M61 00001001BD631C 00001002BD6379 00001011BD6641 00001012BD66F7 00000PH150014A 00000PH150319A 00000PH150329A 00000PH150377A 00000283431MR5 00000284207MR8 00002UA9300HNM 00000012016YR2 00000013024YR5 00000013230YR8 00000013605YR1 00000013791YR9 00000013884YR2 00000014042YR6 00000014077YR2 00000015592YR9 00000016030YR9 00000292983MR4 00000296037MR5 00000296108MR4 00000298410MR2 00000298933MR3 00000299274MR1 00000299666MR8 00001018XF5033 00001018XF5035 00001027XF5008 00001037XF507E 00001037XF5078 00001042XF502A 00001042XF503B 00001043XF500A 00001043XF500C 00001043XF500D 00001043XF5011 00001046XF500C 00001046XF5016 00001046XF5018 00001046XF502D 00001047XF5001 00001048XF5011 00001048XF5016 00001049XF500E 00001049XF5028 00001052XF5008 00001101XF50A6 00001101XF50DA 00001101XF500D 00001102XF506C 00001102XF5077 00001105XF5003 00001105XF5010 00001105XF5026 0000SGH136SZ08 0000SGH136SZ1M 0000SGH139QLFS 0000SGH139QLGX 0000SGH139QLG0 0000SGH139QLHM 0000SGH201TZ0J 0000SGH203QRPG 0000SGH203QRQ7 0000SGH205RQ0Y 0000SGH212RCRM 0000SGH212RCR3 0000SGH231PPQH 0000SGH231PPQS 0000SGH242RN1D 0000SGH245TP29 0000SGH247Q8C3 00002UA2050JKB 00002UA2050JKN 00002UA2050JKR 00002UA2050JKT 00002UA2050JK3 00002UA2050JK4 00002UA2050JL5 00002UA2070RGX 00002UA211170M 00002UA2281GGJ 00002UA24907WB 00002UA2510YTF 00000299545MR4 00000265628MR8 00000266452MR2 00000267728MR4 00000267860MR5 00000268046MR0 00000270098MR7 00000270528MR3 00000294647MR3 00000297160MR4 00000297710MR6 00000297870MR8 00000298538MR0 00000298539MR8 00000298540MR6 00000298541MR4 00000298570MR3 00000299247MR7 00000299553MR8 00000300609MR5 00000300610MR3 00000300611MR1 00000300613MR7 00000300697MR0 00000302984MR0 00000302988MR1 00000303359MR4 00000303407MR1 00000303410MR5 00000303864MR3 00000

Risk classification

Class II

Area (FDA)

device

Country

United States