medical Class II Updated 2018-10-31

GE Medical Systems, LLC recalls GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050

Recalled Product

GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Usage The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as an accessory to produce 2D and 3D images.

Hazard / Issue

Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue.

Issued by

FDA

Affected States: AZ, CA, CO, IL, IN, MI, MN, NY, OH, OK, SD, TX, WI, VA, DE, FL, MD, ME, MO, NC, NH, OR, PA, TN, DC

Lot/Code Info: Mfg Lot or Serial # System ID 00000001140049 BMDACCMR1 00000001140050 BMDACCMR1 0000011-4-0050 BMDACCMR1 0000011-4-0009 920568MR3T 0000011-4-0015 920568MR3T 0000011-4-0017 602406IMR 0000011-4-0018 602406IMR 0000011-4-0024 602406IMR 0000014-4-0007 602406IMR 0000011-4-0028 626359MR3 0000011-4-0032 626359MR3 0000011-4-0046 MSK68MR4 0000011-4-0047 MSK68MR4 0000028-3-0011 MSK68MR4 0000044-4-0046 MSK68MR4 0000011-4-0064 415CB3TW 0000011-4-0065 415CB3TW 0000011-4-0066 415723SHAW12 0000011-4-0067 415723SHAW12 0000011-4-0075 616267IMRI 0000011-4-0076 616267IMRI 011-4-0085 616267IMRI 011-4-0170 616267IMRI 0000011-4-0094 330344MR750W 011-4-0118 330344MR750W 0000011-4-0101 713792CMR1 0000011-4-0102 713792CMR1 0000011-4-0107 317887MR3 0000011-4-0108 317887MR3 0000011-4-0114 309655MR750W 0000011-4-0115 309655MR750W 011-4-0117 517353DVMR 011-4-0172 517353DVMR 011-4-0119 614293MR9 011-4-0120 614293MR9 011-4-0124 MR229050 077-4-0123 MR229050 011-4-0125 6053223TMR 011-4-0126 6053223TMR 011-4-0129 6053223TMR 011-4-0130 6053223TMR 011-4-0146 480342MR3 011-4-0149 480342MR3 011-4-0154 773665SJMR2 011-4-0155 773665SJMR2 011-4-0162 720848MR4 011-4-0164 720848MR4 0000011-4-0055 415723SCHMR2 0000011-4-0062 405271OUCMR 0000011-4-0080 847872ZMR2 0000011-4-0106 949760MR3 011-4-0169 415UCBHMR3 MISSING_SN_GON4217108 408358SHMR13 Missing_SN_GON4227287 309655IMRI 0000011-4-0019 416369MR3T 0000011-4-0020 416369MR3T 011-4-0128 E416249MR2 11-4-0127 E416249MR2 0000011-4-0027 082427040101 0000011-4-0033 082427040101 0000011-4-0133 082427040167 0000011-4-0134 082427040167 0000011-4-0086 CS1006MR03 0000011-4-0092 CS1006MR03 0000011-4-0153 CS1006MR03 0000011-4-0158 A5547422 0000011-4-0159 A5547422 0000011-4-0103 EM0229 0000011-4-0104 EM0229 0000011-4-0156 EM0276 0000011-4-0157 EM0276 0000011-4-0165 EM0276 0000011-4-0166 EM0276 0000028-4-0016 RTD0191 0000011-4-0060 RTD0191 0000011-4-0061 RTD0191 0000011-4-0093 0920279024 0000011-4-0098 0920279024 0000011-4-0034 PER08626 0000011-4-0035 PER08626 0000011-4-0056 RO1098MR02 0000011-4-0057 RO1098MR02 0000011-4-0030 ZA2169MR01 0000011-4-0031 ZA2169MR01 0000011-4-0042 690120MR01 0000011-4-0043 690120MR01 0000011-4-0044 786090MR06 0000011-4-0045 786090MR06 0000011-4-0143 06162MRS01 0000011-4-0144 06162MRS01

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