Device Recall Optima

OptimaXR200amx PN 5555000-3, PN5555000-4

Radiology Devices

2

No

US Distribution to the states of: AZ, FL, GA, MO and WI.

GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx

OptimaXR220amx PN 5555000-5, PN5555000-6

Radiology Devices

2

No

US Distribution to the states of: AZ, FL, GA, MO and WI.

GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx

Mfg Lot or Serial # System ID 00000085795HL3 812265CL1 00000086408HL2 313343IN1 00000087377HL8 361888CRC 00000089316HL4 201541LAB1 00000091432HL5 615396CV1 00000092611HL3 910671CL323A 00000095315HL8 910671CL323B 00000096904HL8 337494CATH1 00000097546HL6 631654INNOVA 00000097777HL7 937592OPT 00000098434HL4 504568INNOVA41 00000098435HL1 702616RDL31 00000098828HL7 843339INNOVA2 00000098977HL2 202269INNOVA 00000099837HL7 520417OPT3100 00000101009HL9 308865KR31 00000101825HL8 216778LABC 00000112807HL3 517353CATH 00000115275HL0 407CCE323 00000116573HL7 509837SSCL1 00000117808HL6 GON4173729 00000118032HL2 812284IN31 00000118368HL0 318330INNOVA1 00000118712HL9 361788CL323 00000118714HL5 806358INNOVA 00000119286HL3 912384CL 00000119585HL8 GON4263188 00000120996HL4 GON4263188 00000121694HL4 229890CL 00000121719HL9 520GVHCATH 00000124905HL1 217443PUSAM323 00000124965HL5 941483CL1 00000126533HL9 702880CATH1 00000127011HL5 318704CATH2 00000110028HL8 DZ1605VA01 00000108050HL6 082416090051 00000112754HL7 082416230024 00000113435HL2 GON4217188 00000113700HL9 082416010027 00000113963HL3 082416090050 00000113977HL3 082416090047 00000116179HL3 082416090058 00000116903HL6 082416100086 00000117226HL1 082416090053 00000117334HL3 082416120042 00000117414HL3 GON4229674 00000117572HL8 GON4242594 00000119287HL1 082416090062 00000119871HL2 082416210033 00000120419HL7 082416190023 00000120578HL0 082416190021 00000120736HL4 082416090059 00000120847HL9 082416090064 00000120867HL7 082416100085 00000120982HL4 082416060016 00000121662HL1 082416090067 00000122668HL7 082416140017 00000122850HL1 082416250010 00000123076HL2 082416180016 00000123319HL6 082416310033 00000123501HL9 082416050013 00000123712HL2 082416200021 00000124692HL5 082416190022 00000125706HL2 082416100095 00000125713HL8 082416190024 00000125813HL6 082416030027 00000125876HL3 082416030028 00000125896HL1 082416110023 00000126170HL0 082416070041 00000126248HL4 082416010028 00000126340HL9 082416200020 00000126419HL1 082416100096 00000126437HL3 082416100093 00000126690HL7 082416090069 00000126899HL4 082416240010 00000127446HL3 082416090071 00000127737HL5 GON4336456 00000127862HL1 082416290009 00000128225HL0 082416250011 00000128502HL2 082416210035 00000128654HL1 082416070045 00000128767HL1 082416160051 00000128873HL7 082416070044 00000128977HL6 082416020018 00000129200HL2 082416030030 00000129201HL0 082416110027 00000127175HL8 GON4272817 00000121740HL5 GE1161VA01 00000124022HL5 083016843923015 00000122051HL6 0835160056 00000126571HL9 A5185810 00000100200HL5 LB1064VA02 00000121474HL1 LB1001VA01 00000108264HL3 MQ1008VA02 00000114646HL3 MA1541VA01 00000115595HL1 MA1528VA01 00000115655HL3 MA1422VA01 00000114362HL7 PL3243VA01 00000116222HL1 RO1180VA03 00000101672HL4 RU3412VA02 00000105449HL3 RU3412VA02 00000117581HL9 RU8999VA01 00000102617HL8 GPX25909 00000114902HL0 XV114950HL9 00000107206HL5 71006VAS01 00000114949HL1 35054VAS01 00000121381HL8 65020VAS01 00000101147HL7 UZ1027VA01

Radiology Devices

2

No

Worldwide Distribution - US Nationwide in the states of: AR, AZ, DC, FL, GA, IL, IN, LA, MI, NC, NE, NJ, NV, NY, OH, SC, TN, TX, WA. and the countries of Algeria, Bangladesh, Bosnia and Herzegovina, Brazil, China, Dominican Republic, Ethiopia, Georgia, Germany, India, Indonesia, Italy, Lebanon Martinique , Morocco, Poland, Republic of Moldova, Russia, Spain Thailand, Trinidad, Turkey, and Uzbekistan.

GE Healthcare Optima CL323i || Product Usage: || The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures.

00000116342HL7 BA4020VA03 00000127265HL7 XVV1S15019 00000124734HL5 XV124857HL4 00000121103HL6 HC1251XR03 00000102618HL6 083016020038813 00000128170HL8 083016061894915 00000115935HL9 083016100119314 00000125802HL9 083016200031715 00000123471HL5 083016208011415 00000118232HL8 083016240028414 00000122806HL3 083016247131115 00000112586HL3 083016280008314 00000119769HL8 083016284903114 00000122805HL5 083016287138315 00000114746HL1 083016289336814 00000116996HL0 083016601010614 00000112287HL8 083016801002714 00000108901HL0 083016801024714 00000122417HL9 083016807113615 00000109262HL6 083016807511514 00000123932HL6 083016809698915 00000119571HL8 083016824740714 00000110467HL8 083016846514214 00000104227HL4 083016860037213 00000125616HL3 083016860528415 00000113585HL4 083016861004214 00000128059HL3 083016862769215 00000126960HL4 083016029472715 00000120518HL5 083016866085914 00000120528HL5 GON4260859 00000010594HL3 083016844488913 00000105944HL3 GON4144889 00000129362HL0 0004344218 00000122667HL9 5512XR0010 00000124068HL8 5512XR0032 00000124830HL1 5512XR0033 00000124904HL4 5512XR0025 00000125415HL0 5512XR0034 00000129237HL4 GON4344915 00000115056HL4 PL3480VA01 00000128693HL9 1573XR0032 00000121982HL3 42026VAS01

Radiology Devices

2

No

Worldwide Distribution - US Nationwide in the states of: AR, AZ, DC, FL, GA, IL, IN, LA, MI, NC, NE, NJ, NV, NY, OH, SC, TN, TX, WA. and the countries of Algeria, Bangladesh, Bosnia and Herzegovina, Brazil, China, Dominican Republic, Ethiopia, Georgia, Germany, India, Indonesia, Italy, Lebanon Martinique , Morocco, Poland, Republic of Moldova, Russia, Spain Thailand, Trinidad, Turkey, and Uzbekistan.

GE Healthcare Optima IGS 320. || Product Usage: || The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures.

0001272012-001 615VEMR 0003062012-008 605328SMR15 0012102012-001 SMRDEMO01 0005162012-003 801243MR2 SM05132013-001 970879MR430 SM10172011-004 509482MR3 SM06142013-001 641428ONI SM10302012-006 ARIA430S SM06272013-006 207OA430MR SM11262012-007 USOTCSMR SM07082013-012 719766SMR 0SM5312013-001 760725MR1 SM08152013-002 703805ONIMR4 SM11252013-001 310665MR 0000SM09202013 208557MR2 SM05212013-004 VAD430 SM11132012-002 856581MR430 SM12172012-001 303577MR2 0001212012-001 786308MR1 0012222011-001 973586MR 0006012011-001 SINAI601 0007132011-001 516482MR430 0012042011-001 MKMG430S 0 02162012-001 805679ONI 0012142011-001 215DOY430S 0006112012-004 360786ONIMR 0003062012-007 212288ONI 0010272011-009 513636NICMR 0003282012-001 518453MR2 0002112012-001 803434ONI Missing_SN_GON4194272 402EXTMR SM03132014-002 H430SMR SM05142014-006 520VAONIMR SM07182014-009 352376ONI1 SM11062012-001 MRSM11062012001 0002022012-001 0910272081 0004212012-001 514697ONI SM01232014-003 SM01232014-003 SM05192014-003 MRSM05192014003 0005252012-002 MRMEDSMR3 SM02252014-003 082427010079 SM03292014-007 082427020055 SM05272014-007 082427020060 SM09202013-017 082427040145 0SM0225013-004 082427030080 SM06202013-002 MRSM06182013002 SM01202014-014 DK1000MR04 SM10242013-002 DK1075MR01 0000DK1030MR03 DK1030MR03 0012132011-001 DK1068MR01 0001192012-001 FI1378MR01 0011052011-002 FI1006MR02 SM01102014-001 M24070304 SM01152013-001 L1650217 SM03052014-004 M176430610 SM04152014-001 M5817305 SM04292014-002 M2862820 SM07182014-014 M172471308 SM08152013-003 M4215583 SM12192013-003 M219000205 SM02042014-003 D4185525 SM07182014-008 0828270040 0002042012-001 IS1019MR01 SM10122012-003 A5177233 SM12102012-003 A287971801 0007172011-001 A127292410 0009242011-001 A5725513 SM02132014-001 OM0005 SM03202014-001 OM0004 SM11122013-007 OM0003 SM12202013-001 OM0100 0005102012-004 OM0001 0008022012-003 OM0002 0007302012-008 0850270400 SM07182014-012 KW1019MR04 SM07182014-013 KW1001MR05 0005152012-004 DRD0120 SM07142014-003 GRN0121 SM01072013-005 SM01072013-005 0005032012-004 PL2783MR01 SM04212014-003 PPR74710 0008032012-001 RU1086MR04 SM03062013-001 0847270030 SM07152013-008 0847270032 0010172011-001 0847270028 SM04072014-012 ZA2630MR01 SM08152012-001 ZA2458MR01 SM03142013-002 NPV15969 SM10162013-004 CEZ01534 0003092012-001 MPX19500 0004172012-001 DPN26330 0007112011-001 UP925714 0010092011-001 DPN89106 0010242011-007 UPW01900 0011052011-001 NPV22527 0012262011-001 MPX27417 0008102011-001 N006MR02 SM07182014-007 C001MR02 SM11212013-001 AE1444MR01 0001232012-001 10476MRS01 0008152010-001 0910272078

Radiology Devices

2

No

US: AL, AZ, CA, CO, FL, ID, IL, IA,ME, NE, NV,NH, NJ, NY, NC, OH, PA, SC, SD, TN, TX, UT,VA, WA, WI. OUS: Argentina Australia Austria Brazil Canada Chile Colombia Denmark Egypt Finland France Germany Greece Hong Kong Iceland Italy Japan Korea (Republic of) Kuwait Malaysia Netherlands Norway Peru Poland Portugal Russia Singapore South Africa Spain Sweden Switzerland Ukraine United Arab Emirates United Kingdom

Optima 1.5T MR430s MR Scanner, a diagnostic imaging device