GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.
Check against the official notice below — it lists the full affected range.
GE Healthcare has issued a recall for the 3.0T 6 Channel Flex Coil used with 3T MR750W Surgical Suite Scanners and Discovery 3.0T MR750 systems running certain application software versions. The potential safety issue is that the coil can overheat when the device is used in Mode 2 setup, which could cause serious thermal injury to patients. No injuries have been reported from this issue. The recall affects 356 devices worldwide, including 98 in the United States distributed across multiple states and 258 outside the United States across numerous countries.
The recall includes devices with specific serial numbers and system IDs listed in the manufacturer documentation. The record does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners. 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. UPDATE 5/27/2016: Recall has been updated to include an additional product which includes the Discovery 3.0T MR750 systems running Application Software DV24 R01, DV25 R02, or DV25.1 M3.
Reason for recall: GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners. 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. UPDATE 5/27/2016: Recall has been updated to include an additional product which includes the Discovery 3.0T MR750 systems running Application Software DV24 R01, DV25 R02, or DV25.1 M3. 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: 356 (98 US; 258 OUS) Lot/code info: Mfg Lot or Serial # System ID 000000HDMR6188 301496MR3T4 000873824-0007 82427140106 00001105XF503F ASLW750 00001026XF518E 82427180022 00001048XF500F 82427210091 00001106XF5125 82427120092 00001106XF512A 82427120097 00001106XF5105 82427260003 00001105XF5030 82427040143 0000000UA0199A 82427040146 00001307FMM04C 82427200058 00000005271M22 82427210118 00000000395M24 EM0003 00000000WB0792 82427200076 641 434UVAMR 00000950BD62C2 G001MR01 00000914BD5A87 910272064 00001007BD6466 910272071 00001011BD663A 910272072 00001012BD66AE MRWB0558 00001009BD65AC 82427230048 00001009BD65A1 82427210068 00001012BD6696 82427230051 00001010BD6607 600110MR01 00000952BD62F0 EG1793MR01 00000903BD55F9 M4215566 00001002BD639D M40180117 00000914BD5A86 615010MR01 00000934BD5E44 J5274809 00000905BD567C A5279314 00000926BD5D00 2806034DVR750 00001007BD6471 RU3508MR01 00000919BD5B81 SA2180MR02 00001011BD6689 E001MR02 00000848BD5326 K002MR02 00000931BD5D88 853270103 00000944BD6163 853270104 00001009BD65E7 853270109 00001011BD6639 70065MRS03 00000931BD5D89 70328MRS05 00000836BD4DB5 475290MR01 00000291244MR2 MSK65MR2 00000293015MR4 910907WAMR1 00000296461MR7 MR129037 00000297637MR1 650723PSYMR 00000293065MR9 918491MR1 00000291464MR6 217528MR1 00000289961MR5 SINAI750MR 00000290050MR4 281276MR750 00000290659MR2 610740MR3 00000291363MR0 616391DVMR 00000291980MR1 704384DVMR 00000292367MR0 INSIGHTMR3228 00000292471MR0 804675VA3T 00000292634MR3 2486613TMR 00000293874MR4 HSSGMR750 00000292431MR4 541CMRIMR 00000290773MR1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.