Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging…

Date

Jan. 16, 2019

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare, LLC

Product

Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use

Reason

Possible incorrect software version loaded.

Distribution pattern

Worldwide Distribution - US Nationwide AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Canada, China, Colombia, Cyprus, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Italy, Jamaica, Japan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Mauritania, Mauritius, Mexico, Moldova, Morocco, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam and Zambia

Quantity

3,849

Codes and lots

Product Name Sold Under System ID Model # *WH*MR SIGNA 1.0T HORIZON 5.X HISPE GPX23300 2108050 0.2T SIGNA PROFILE 2761614-1 5179427 0.7T OPENSPEED EXITE PC7479MR06 2377062-5 0.7T OPENSPEED EXITE PC3802MR02 2377062-5 1,5T HD ES/HS 10079MRM74 5107849 1.0T SIGNA LX PH0095MR01 2214149 1.0T SIGNA LX PC0125MR02 2189500-3 1.5 ECHOSPEED HD 16-CH 0850270514 2226300 1.5 ECHOSPEED HD 4-CH 200-AP 409838HDCMR1 46-294231G1 1.5 ECHOSPEED HD 4-CH 200-AP 940220MR1 2214149-2 1.5 ECHOSPEED HD 8-CH 400-A 1344119 2226300 1.5 ECHOSPEED HD 8-CH 400-A 2624537EXCITE 5107849-2 1.5 ECHOSPEED HD 8-CH 400-AP 760323MR 2214149-2 1.5 ECHOSPEED HD 8-CH 400-AP 60001MRS01 5323286-101 1.5 HDE 8CH 3882691524MRCTR 5139394-2 1.5 HISPEED 3882635801MRSOR 2226300 1.5 HISPEED 4C 412099MR1 2226300 1.5 HISPEED HD 8-CH 400-AP 317338MR4 2214149-2 1.5 HISPEED HD 8-CH 400-AP 803936MRI 2214149-2 1.5 LX TO HDX 16C FORKLIFT UPG 614293MR7 2214149-2 1.5 SIGNA EXPLORER DZ1947MR01 5323286-101 1.5 SIGNA EXPLORER DZ1149MR02 5323286-101 1.5 T ECHOSPEED HD 4-CH 200-AP 35067MRS01 5107849-2 1.5 T ECHOSPEED MRI LY1006MR01 2189500-3 1.5 TWINSPEED HD 8CH-400-AP 910716BMR1 2377062-2 1.5T BRIVO MR355 AZ4010MR01 5341543 1.5T BRIVO MR355 AZ4027MR01 5341543 1.5T BRIVO MR355 AZ4004MR01 5323286 1.5T BRIVO MR355 AZ4015MR01 5341380 1.5T BRIVO MR355 082427010062 2214149-2 1.5T BRIVO MR355 082427210103 5341543 1.5T BRIVO MR355 082427210079 5341543 1.5T BRIVO MR355 082427200079 2214149-2 1.5T BRIVO MR355 082427310067 5341543 1.5T BRIVO MR355 082427040126 5341543 1.5T BRIVO MR355 082427110037 5341543 1.5T BRIVO MR355 082427190054 5323286 1.5T BRIVO MR355 082427190056 5341543 1.5T BRIVO MR355 082427270035 5341543 1.5T BRIVO MR355 082427190060 5341543 1.5T BRIVO MR355 082427190058 5341543 1.5T BRIVO MR355 082427230054 5341543 1.5T BRIVO MR355 082427230062 5341543 1.5T BRIVO MR355 082427220028 5341543 1.5T BRIVO MR355 082427220029 5341543 1.5T BRIVO MR355 082427220030 5341543 1.5T BRIVO MR355 082427220032 5341543 1.5T BRIVO MR355 082427170015 5341543 1.5T BRIVO MR355 082427150052 5323286 1.5T BRIVO MR355 082427210126 5341543 1.5T BRIVO MR355 082427010059 5341543 1.5T BRIVO MR355 082427100163 5341543 1.5T BRIVO MR355 082427240027 5341543 1.5T BRIVO MR355 082427210086 5341380 1.5T BRIVO MR355 082427160108 5341543 1.5T BRIVO MR355 082427200044 5341543 1.5T BRIVO MR355 082427150055 5341543 1.5T BRIVO MR355 082427200064 5341543 1.5T BRIVO MR355 082427020040 5341380 1.5T BRIVO MR355 082427110038 5341543 1.5T BRIVO MR355 082427160096 5341543 1.5T BRIVO MR355 082427160099 5341543 1.5T BRIVO MR355 082427240040 5341543 1.5T BRIVO MR355 082427090167 5341543 1.5T BRIVO MR355 082427100183 5341543 1.5T BRIVO MR355 082427090191 5341543 1.5T BRIVO MR355 082427020048 5341543 1.5T BRIVO MR355 082427200054 2214149-2 1.5T BRIVO MR355 082427210092 5341543 1.5T BRIVO MR355 082427090177 5341543 1.5T BRIVO MR355 082427100155 5341543 1.5T BRIVO MR355 082427090184 5341543 1.5T BRIVO MR355 082427030077 5341543 1.5T BRIVO MR355 082427100160 5341543 1.5T BRIVO MR355 082427100151 5341543 1.5T BRIVO MR355 082427190063 2214149-2 1.5T BRIVO MR355 082427100167 5341543 1.5T BRIVO MR355 082427180026 5341543 1.5T BRIVO MR355 082427240033 5341543 1.5T BRIVO MR355 082427090197 5341380 1.5T BRIVO MR355 082427090158 5341543 1.5T BRIVO MR355 082427090185 5341543 1.5T BRIVO MR355 082427230070 5341543 1.5T BRIVO MR355 082427230060 5341543 1.5T BRIVO MR355 082427200051 5341543 1.5T BRIVO MR355 082427180025 5341543 1.5T BRIVO MR355 082427090154 5341543 1.5T BRIVO MR355 082427090199 5341543 1.5T BRIVO MR355 082427090183 5341543 1.5T BRIVO MR355 082427320001 5341543 1.5T BRIVO MR355 082427220025 5341543 1.5T BRIVO MR355 082427020043 5341543 1.5T BRIVO MR355 082427070091 5341543 1.5T BRIVO MR355 082427090172 5341543 1.5T BRIVO MR355 082427090155 5341543 1.5T BRIVO MR355 082427150046 5341543 1.5T BRIVO MR355 082427200055 5341543 1.5T BRIVO MR355 082427200059 5341543 1.5T BRIVO MR355 082427090216 5341543 1.5T BRIVO MR355 082427190057 5341543 1.5T BRIVO MR355 082427190059 5341543 1.5T BRIVO MR355 082427030068 5341543 1.5T BRIVO MR355 082427070092 5341543 1.5T BRIVO MR355 082427020046 5341543 1.5T BRIVO MR355 082427090156 5341543 1.5T BRIVO MR355 082427170017 5341543 1.5T BRIVO MR355 082427200061 5341543 1.5T BRIVO MR355 082427310051 2214149-2 1.5T BRIVO MR355 082427210088 5341543 1.5T BRIVO MR355 082427110039 5341380 1.5T BRIVO MR355 082427070077 5341543 1.5T BRIVO MR355 082427090205 5341543 1.5T BRIVO MR355 082427090162 5341543 1.5T BRIVO MR355 082427090152 5341543 1.5T BRIVO MR355 082427230076 5341543 1.5T BRIVO MR355 082427100162 5341380 1.5T BRIVO MR355 082427230072 5341543 1.5T BRIVO MR355 082427210085 5341543 1.5T BRIVO MR355 082427200063 5341543 1.5T BRIVO MR355 082427200069 5341543 1.5T BRIVO MR355 082427190062 5341543 1.5T BRIVO MR355 082427190068 5341543 1.5T BRIVO MR355 082427190051 5341543 1.5T BRIVO MR355 082427150049 5341543 1.5T BRIVO MR355 082427170018 5341543 1.5T BRIVO MR355 082427090186 5341543 1.5T BRIVO MR355 082427190052 5341543 1.5T BRIVO MR355 GH1043MR01 5323286 1.5T BRIVO MR355 083027842855011 5341380 1.5T BRIVO MR355 083027849948410 5341380 1.5T BRIVO MR355 083027841020511 5341543 1.5T BRIVO MR355 083027849928710 5341380 1.5T BRIVO MR355 083027600051013 5341543 1.5T BRIVO MR355 083027280005313 5341543 1.5T BRIVO MR355 083027007207410 5341543 1.5T BRIVO MR355 083027240003113 5341543 1.5T BRIVO MR355 083027240009512 5341380 1.5T BRIVO MR355 083027001561512 5341543 1.5T BRIVO MR355 083027100004713 5341543 1.5T BRIVO MR355 083027009119914 5341543 1.5T BRIVO MR355 083027821003113 5341543 1.5T BRIVO MR355 083027860004512 5341543 1.5T BRIVO MR355 083027861011112 5341380 1.5T BRIVO MR355 083027860028112 5341380 1.5T BRIVO MR355 083027860044912 5341380 1.5T BRIVO MR355 083027868443311 5341543 1.5T BRIVO MR355 083027200037012 5341380 1.5T BRIVO MR355 083027206937710 5341543 1.5T BRIVO MR355 083027207969111 5341380 1.5T BRIVO MR355 083027044291311 5341380 1.5T BRIVO MR355 083027800405712 5341543 1.5T BRIVO MR355 083027000020213 5341543 1.5T BRIVO MR355 083027000004112 5341380 1.5T BRIVO MR355 0835270047 2214149-2 1.5T BRIVO MR355 0835270033 5341543 1.5T BRIVO MR355 0835270023 5341543 1.5T BRIVO MR355 0835270030 2214149-2 1.5T BRIVO MR355 0850270390 5341543 1.5T BRIVO MR355 0850270356 5341543 1.5T BRIVO MR355 0850270352 5341543 1.5T BRIVO MR355 LV4058MR01 5323286 1.5T BRIVO MR355 0834270018 5323286 1.5T BRIVO MR355 MA1085MR01 5341543 1.5T BRIVO MR355 MA1421MR01 5323286 1.5T BRIVO MR355 MA1014MR02 5323286 1.5T BRIVO MR355 NG1116MR01 5323286 1.5T BRIVO MR355 RU1778MR01 5341543 1.5T BRIVO MR355 RU2272MR01 5341380 1.5T BRIVO MR355 RU3951MR01 5323286 1.5T BRIVO MR355 0856270056 5341543 1.5T BRIVO MR355 0856270054 5341543 1.5T BRIVO MR355 0856270069 5341380 1.5T BRIVO MR355 0856270051 5341543 1.5T BRIVO MR355 0856270058 5341543 1.5T BRIVO MR355 0856270055 5341543 1.5T BRIVO MR355 0856270060 5341543 1.5T BRIVO MR355 0856270057 5341543 1.5T BRIVO MR355 09015MRS01 5323286 1.5T BRIVO MR355 13007MRS01 5341543 1.5T BRIVO MR355 UZ1020MR01 5341543 1.5T BRIVO MR355 0859270017 5341543 1.5T BRIVO MR355 0859270018 5341543 1.5T BRIVO MR355 0859270016 5341543 1.5T BRIVO MR355 . MA1479MR01 5341543 1.5T BRIVO MR355 23.0 HYBD 083027204833215 2226300 1.5T BRIVO MR355 ON 23.0 MRR10630 2214149-2 1.5T BRIVO MR355 ON 23.0 MRR10371 2214149-2 1.5T BRIVO MR355 ON 23.0 MRR10739 2214149-2 1.5T BRIVO MR355 ON 23.0 MRR10001 5341543 1.5T BRIVO MR355 ON 23.0 MRR10655 2214149-2 1.5T BRIVO MR355 ON 23.0 MRR10294 5341543 1.5T BRIVO MR355 ON 23.0 AM1015MR01 5341543 1.5T BRIVO MR355 ON 23.0 MRR10200 5341543 1.5T BRIVO MR355 ON 23.0 MRR10269 5341543 1.5T BRIVO MR355 ON 23.0 MRR9933 5341543 1.5T BRIVO MR355 ON 23.0 MRR10116 5341543 1.5T BRIVO MR355 ON 23.0 082427280015 2214149-2 1.5T BRIVO MR355 ON 23.0 082427150072 5341543 1.5T BRIVO MR355 ON 23.0 082427210133 5341543 1.5T BRIVO MR355 ON 23.0 082427210078 5341543 1.5T BRIVO MR355 ON 23.0 082427210139 2214149-2 1.5T BRIVO MR355 ON 23.0 082427190083 5341543 1.5T BRIVO MR355 ON 23.0 082427200084 2214149-2 1.5T BRIVO MR355 ON 23.0 082427010096 2214149-2 1.5T BRIVO MR355 ON 23.0 082427030097 5341543 1.5T BRIVO MR355 ON 23.0 082427030113 2214149-2 1.5T BRIVO MR355 ON 23.0 082427080050 2214149-2 1.5T BRIVO MR355 ON 23.0 082427090271 2214149-2 1.5T BRIVO MR355 ON 23.0 082427240056 2214149-2 1.5T BRIVO MR355 ON 23.0 MRR10144 5341543 1.5T BRIVO MR355 ON 23.0 MRR9948 5341543 1.5T BRIVO MR355 ON 23.0 MRR10220 5341543 1.5T BRIVO MR355 ON 23.0 MRR10061 5341543 1.5T BRIVO MR355 ON 23.0 GE1175MR01 2214149-2 1.5T BRIVO MR355 ON 23.0 083027805146514 2214149-2 1.5T BRIVO MR355 ON 23.0 083027848755514 5341543 1.5T BRIVO MR355 ON 23.0 083027801462314 5341543 1.5T BRIVO MR355 ON 23.0 0835270066 5341543 1.5T BRIVO MR355 ON 23.0 0835270037 5341543 1.5T BRIVO MR355 ON 23.0 0835270046 5341543 1.5T BRIVO MR355 ON 23.0 0835270040 2214149-2 1.5T BRIVO MR355 ON 23.0 A5730102 5341543 1.5T BRIVO MR355 ON 23.0 KE1077MR01 2214149-2 1.5T BRIVO MR355 ON 23.0 0850270465 5341543 1.5T BRIVO MR355 ON 23.0 0850270464 5341543 1.5T BRIVO MR355 ON 23.0 0850270431 5341543 1.5T BRIVO MR355 ON 23.0 0850270434 5341543 1.5T BRIVO MR355 ON 23.0 0850270433 5341543 1.5T BRIVO MR355 ON 23.0 LB1406MR01 5341543 1.5T BRIVO MR355 ON 23.0 1553MR0002 2214149-2 1.5T BRIVO MR355 ON 23.0 1553MR0001 2214149-2 1.5T BRIVO MR355 ON 23.0 MA1526MR01 5341543 1.5T BRIVO MR355 ON 23.0 PA1051MR01 2214149-2 1.5T BRIVO MR355 ON 23.0 0843270024 5341543 1.5T BRIVO MR355 ON 23.0 RO1259MR01 5341543 1.5T BRIVO MR355 ON 23.0 RU8755MR01 5341543 1.5T BRIVO MR355 ON 23.0 RU8622MR01 5341543 1.5T BRIVO MR355 ON 23.0 RU7635MR01 5341543 1.5T BRIVO MR355 ON 23.0 RU7809MR01 2214149-2 1.5T BRIVO MR355 ON 23.0 RU9376MR01 5341543 1.5T BRIVO MR355 ON 23.0 RU1354MR01 5341543 1.5T BRIVO MR355 ON 23.0 RU1017MR01 5341543 1.5T BRIVO MR355 ON 23.0 6073MR0005 5341543 1.5T BRIVO MR355 ON 23.0 06156MRS01 5341543 1.5T BRIVO MR355 ON 23.0 33036MRS01 5341543 1.5T BRIVO MR355 ON 23.0 UZ1035MR01 5341543 1.5T BRIVO MR355 ON 23.0 MRR10278 5341543 1.5T BRIVO MR355 ON 23.0 5973MR0003 5341543 1.5T BRIVO MR355 ON 23.0 0859270019 5341543 1.5T BRM LX TO 16CH HD23 UP 08962 2226300 1.5T BRM LX TO 16CH HD23 UPGRA 205939MR2 46-294231G1 1.5T BRM LX TO 16CH HD23 UPGRA 205345MRI 46-294231G1 1.5T BRM LX TO 16CH HD23 UPGRA ALLIANCESIG209 46-294231G1 1.5T BRM LX TO 16CH HD23 UPGRA 209577MRMR 46-294231G1 1.5T BRM LX TO 16CH HD23 UPGRA ALLIANCESIG282 2214149-2 1.5T BRM LX TO 16CH HD23 UPGRA 909748MR 2214149-2 1.5T BRM LX TO 16CH HD23 UPGRA 209536SMR M3000PT 1.5T BRM LX TO 16CH HD23 UPGRA INSIGHTMR1304 2214149-2 1.5T BRM LX TO 16CH HD23 UPGRA ALLIANCESIG261 46-294231G1 1.5T BRM LX TO 16CH HD23 UPGRA 813968MR 2214149-2 1.5T BRM LX TO 16CH HD23 UPGRA 904732MRLX 2226300 1.5T BRM LX TO 16CH HD23 UPGRA 954433MR1 2214149-2 1.5T BRM LX TO 16CH HD23 UPGRA 954746MR1 2214149-2 1.5T BRM LX TO 16CH HD23 UPGRA 404352PNC 2214149-2 1.5T BRM LX TO 16CH HD23 UPGRA 620231MMRI 46-294231G1 1.5T BRM LX TO 16CH HD23 UPGRA ALLIANCESIG220 46-294231G1 1.5T BRM LX TO 16CH HD23 UPGRA 662720MR1 2214149-2 1.5T BRM LX TO 16CH HD23 UPGRA INSIGHTMR1812 46-294231G1 1.5T BRM LX TO 16CH HD23 UPGRA INSIGHTMR1275 46-294231G1 1.5T BRM LX TO 16CH HD23 UPGRA SHIMR591 46-294231G1 1.5T BRM LX TO 16CH HD23 UPGRA ALLIANCESIG207 2214149 1.5T BRM LX TO 16CH HD23 UPGRA 513936MR 2226300 1.5T BRM LX TO 16CH HD23 UPGRA 405272SMR 46-294231G1 1.5T BRM LX TO 16CH HD23 UPGRA 503293MR1 46-294231G1 1.5T BRM LX TO 16CH HD23 UPGRA 803256MR 2284300 1.5T BRM LX TO 16CH HD23 UPGRA 864582MR 2284300 1.5T BRM LX TO 16CH HD23 UPGRA 512454RRRMR2 46-294231G1 1.5T BRM LX TO 16CH HD23 UPGRA 281588MR1 46-294231G1 1.5T BRM LX TO 16CH HD23 UPGRA 208367LX11 46-294231G1 1.5T BRM LX TO 16CH HD23 UPGRA 307674SOMR 2214149-2 1.5T BRM LX TO 16CH HD23 UPGRA 083027596090934 2226300 1.5T BRM LX TO 16CH HD23 UPGRA 507130SIGNA 2226300 1.5T BRM LX TO 16CH HD23 UPGRA AE1011MR01 2226300 1.5T BRM LX TO 16CH HD23 UPGRADE DZ1128MR01 2226300 1.5T BRM LX TO 16CH HD23 UPGRADE MA1357MR01 2226300…

Recall started

Nov. 15, 2018

Device type

System, Nuclear Magnetic Resonance Imaging

Root cause (FDA)

Software design

What the company told customers

On November 20, 2018 GE sent letters to all their consignees stating the following: If you have identified that your system has invalid software version, please contact GE Healthcare service representative immediately. This correction applies to some units of the following GE Healthcare MRI system types: Signa OpenSpeed, Signa Infinity with Excite Technology, Signa Excite 3T, Signa Infinity & Signa Infinity Twinspeed, Signa Profile, Signa Ovation .35T, Signa HFO, Signa Ovation with Excite & 0.7T Signa OpenSpeed, Signa Ovation HD, Signa HDe, 1.5T Signa HDxt, Brivo MR355 & Optima MR360, Signa Creator & Signa Explorer. GE Healthcare will inspect all affected systems and ensure the proper software version is installed. This will be performed at no cost to you. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Recall number

Z-0693-2019

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0693-2019. The agency record governs; check it and the company before acting.