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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil see related information
Date Initiated by Firm December 07, 2015
Date Posted December 28, 2015
Recall Status1 Terminated 3 on November 08, 2018
Recall Number Z-0553-2016
Recall Event ID 72892
510(K)Number K110610  
Product Classification Coil, magnetic resonance, specialty - Product Code MOS
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.
Code Information  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                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   
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		 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.
FDA Determined
Cause 2		 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 90 (54 US; 36 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 = MOS and Original Applicant = GE MEDICAL SYSTEMS, LLC
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