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.
Check against the official notice below — it lists the full affected range.
GE Medical Systems is recalling the 3.0T 6 Channel Phased Array Flex Coil, a medical device used in MRI procedures. The device can overheat when used in Mode 2 setup, which could cause serious thermal injury to patients. Although 90 units have been distributed worldwide—54 in the United States across multiple states and 36 internationally in countries including Canada, Japan, Australia, and others—no injuries have been reported as a result of this issue.
The record does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide Distribution- US Distribution including the states of AZ, CA, CO, IL IN, MI, MN, NY, OH, OK, SD, TX, WI, VA, DE, FL, MD, ME, MO, NC, NH, OR, PA, TN, WI, DC, PR and the countries of CANADA, CHINA, CZECH REPUBLIC, ITALY, JAPAN, NETHERLANDS, NEW ZEALAND, PORTUGAL, ROMANIA, SOUTH AFRICA, SWITZERLAND, TURKEY, SWEDEN, AUSTRALIA, BRAZIL, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, ITALY, MEXICO, RU Quantity: 90 (54 US; 36 OUS) 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 082427040
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.