Class 2 Device Recall GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil

• Date Initiated by Firm: December 07, 2015
• Date Posted: December 28, 2015
• Recall Status: Terminated on November 08, 2018
• Recall Number: Z-0201-2019
• Recall Event ID: 72892
• 510(K)Number: K081028 K142085 K142361 K132376
• Product Classification: System, nuclear magnetic resonance imaging - Product Code LNH
• Product: GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.
• Code Information: 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 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• Recalling Firm/ Manufacturer: GE Medical Systems, LLC; 3200 N Grandview Blvd; Waukesha WI 53188-1693
• For Additional Information Contact: GE Healthcare Service; 262-521-6560
• Manufacturer 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.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Consignees were sent on 12/7/2015 a GE Healthcare "Urgent Medical Device Correction" GEHC Ref#60888 letter dated December 7, 2015. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. UPDATE: Consignees were sent a revised letter on May 2, 2016. Previously the letter only listed MR750W Surgical Suite Scanners. Because 3.0T 6 Channel Flex Coils are used with the MR750, MR750W, and 3.0T HDxT (including HD23), these devices have been added to the letter. There are no other changes to the letter. UPDATE 5/27/16: Consignees were sent a revised letter on May 19, 2016. The letter topic stated "De-rating of 3.0T 6 Channel Flex Coil when used on Discovery MR750 running DV24, DV25, or DV25.1 Application Software" . The letter described the Safety Issue, Safety Instruction, Affected Product details, Product Correction and Contact Information (same as previous letter).
• Quantity in Commerce: 356 (98 US; 258 OUS)
• 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, RUSSIA, SAUDI ARABIA, TAIWAN, UNITED KINGDOM, INDONESIA, ESTONIA, REPUBLIC OF KOREA, POLAND, KUWAIT, SPAIN.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LNH and Original Applicant = GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC); 510(K)s with Product Code = LNH and Original Applicant = GE MEDICAL SYSTEMS, LLC