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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1027-2016

NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box. 3.0T GEM Flex, Interface 16ch Fixed, P -Connector, NC032204, GEHC part number 5430008-5. 3.0T GEM Flex Coil16-L Array, NC040200, GEHC part number 5430008-2. 3.0T GEM Flex Coil 16-M Array, NC033000, GEHC part number 5430008-3. 3.0T GEM Flex Coil 16-S Array, NC034200, GEHC part number5430008-4. The 3.0T GEM Flex Coil (interface box and arrays) is used in conjunction with a 3.0T GE Magnetic Resonance Scanner

Publicado el 9 de marzo de 2016 · Inicio del retiro: 18 de diciembre de 2015

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
NeoCoil, LLC
Distribuidor
US Nationwide Distribution
Lote
Mfg Lot or Serial # System ID 0000034-4-0130 608263MR5W 0000040-4-0135 608263MR5W 000032E-4-0151 608263MR5W 033-4-0151 608263MR5W 0000040-4-0202 602863MR 0000033-4-0204 602863MR 034-4-0265 602863MR 040-4-0076 602863MR 0000034-4-0250 703478MR2DV 0000040-4-0270 703478MR2DV 033-4-022 703478MR2DV 0000033-4-0272 703478MR2DV 034-4-0255 506648MR4 040-4-0275 506648MR4 040-4-0020 506648MR4 033-4-0277 506648MR4 034-4-0071 608265MR750W 0000040-4-0381 608265MR750W 0000033-4-0384 608265MR750W 034-4-0345 608265MR750W 0000034-4-0093 708346MR3 0000040-4-0096 708346MR3 0000033-4-0088 708346MR3 034-4-0352 269DVMR 040-4-0392 269DVMR 033-4-0395 269DVMR 0000034-4-0144 808873MR750W 0000033-4-0151 808873MR750W 0000040-4-0150 808873MR750W 0000034-4-0112 270798MR2 0000040-4-0118 270798MR2 0000033-4-0118 270798MR2 034-4-0089 650723NCMR1 033-4-0258 650723NCMR1 033-4-0134 650723NCMR1 0000034-4-0086 281274MR2 0000040-4-0089 281274MR2 0000033-4-0090 281274MR2 0000034-4-0076 757827MR2 0000033-4-0081 757827MR2 0000SGH225PYJJ 757827MR2 0000034-4-0007 305461MR1 0000040-4-0070 305461MR1 0000033-4-0070 305461MR1 0000034-4-0110 847872ZMR2 0000040-4-0114 847872ZMR2 0000033-4-0114 847872ZMR2 0000034-4-0095 330344MR750W 0000040-4-0098 330344MR750W 0000033-4-0099 330344MR750W 0000034-4-0094 616774MR750W 0000040-4-0097 616774MR750W 0000033-4-0098 616774MR750W 0000040-4-0276 386FNSBMR3T 0000033-4-0279 386FNSBMR3T 0000034-4-0260 386FNSBMR3T 0000034-4-0140 217876DMH3T 0000040-4-0145 217876DMH3T 0000033-4-0146 217876DMH3T 0000034-4-0216 410328MR3T 0000040-0-0224 410328MR3T 0000033-4-0227 410328MR3T 034-4-0313 716740MR1 040-4-0329 716740MR1 033-4-0329 716740MR1 0000034-4-0177 415CBMRP 0000040-4-0182 415CBMRP 0000033-4-0183 415CBMRP 0000034-4-0043 808485MR2 0000040-4-0047 808485MR2 033-4-0323 808485MR2 034-4-0267 415UCBHMR1 040-4-0284 415UCBHMR1 033-4-0285 415UCBHMR1 033-4-0352 843815750W 040-4-0055 843815750W 0000034-4-0221 843815750W 034-4-0272 415UCBHMR2 040-4-0288 415UCBHMR2 033-4-0290 415UCBHMR2 0000034-4-0108 856581MR3T 4040109 856581MR3T 0000033-4-0112 856581MR3T 034-4-0380 423493MR750W 040-4-0432 423493MR750W 033-4-0436 423493MR750W 0000034-4-0099 RADNETMR1648 0000040-4-0102 RADNETMR1648 0000033-4-0102 RADNETMR1648 034-4-0369 480342MR3 044-4-0403 480342MR3 033-4-0405 480342MR3 3440372 617726MR1A2 4040420 617726MR1A2 3340423 617726MR1A2 034-4-0069 503251PMR3 040-4-0322 503251PMR3 033-4-0144 503251PMR3 3440200 702382MR750W 4040192 702382MR750W 3340199 702382MR750W 0000-34-4-0235 207MMC3TMR 0000040-4-0249 207MMC3TMR 0000033-4-0252 207MMC3TMR 0000040-4-0291 703573MR1DV 0000033-4-0292 703573MR1DV 0000034-4-0275 703573MR1DV 0000034-4-0189 513636MR4 0000040-4-0196 513636MR4 0000033-4-0198 513636MR4 0000034-4-0188 708346MR4 0000040-4-0195 708346MR4 0000033-4-0197 708346MR4 0000034-4-0055 559734VIMR1 0000040-4-0056 559734VIMR1 0000033-4-0057 559734VIMR1 034-4-0384 720848MR4 040-4-0425 720848MR4 033-4-0428 720848MR4 0000034-4-0143 214645UT3TMR1 0000034-4-0149 214645UT3TMR1 0000034-4-0150 214645UT3TMR1 0000034-4-0115 757983MR 0000033-4-0120 757983MR 0000034-4-0015 757983MR 0000034-4-0037 604875MR750 0000040-4-0033 604875MR750 0000033-4-0044 604875MR750 0000034-4-0033 808545MR 0000040-4-0068 808545MR 0000033-4-0012 808545MR 0000034-4-0282 608262PETMR1 0000040-4-0299 608262PETMR1 0000033-4-0300 608262PETMR1 0000034-4-0138 808YMMR 0000040-4-0148 808YMMR 033-4-0081 808YMMR 034-4-0365 215829MR750W 040-4-0416 215829MR750W 033-4-0420 215829MR750W 034-4-0361 847316MR3T 040-4-0412 847316MR3T 033-4-0414 847316MR3T 0000034-4-0245 914750W 0000040-4-0264 914750W 0000033-4-0267 914750W 0000034-4-0147 856247MR1 0000040-4-0155 856247MR1 0000033-4-0155 856247MR1 0000034-4-0199 937641MR2 0000040-4-0204 937641MR2 0000033-4-0207 937641MR2 034-4-0379 859334MR 040-4-0448 859334MR 033-4-0451 859334MR 0000034-4-0166 COR526967 0000040-4-0179 COR52
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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