Device Recall GE

731030, 731032, 731034, 731036,731038, 731206, 731218, 731220, 731222, 731224, 731226, 731228, 731407, 731506, 731507, 731508, 731509, 731510, 731512, 731514, 731516, 731608, 731809, 732010, 732030, 732032, 732034, 732038, 732211, 732412, 732518, 732520, 732522, 732524, 732526, 732528, 733006, 733007, 733008, 733010, 733012, 733014, 733016, 733018, 733020, 733022, 733024, 733026, 733028, 733030, 733032, 733034, 733036, 733038, 733040, 733042, 734030, 734032, 734034, 734036, 734038, 735018, 735020, 735022, 735024, 735026, 735028, 736006, 736007, 736008, 736010, 736012, 736014, 736016, 736018, 736020, 736022, 736024, 736026, 736028, 736030, 736032, 736034, 736036, 736038, 731206/10/10, 731206/10/10RM, 731206/7, 731407/10/10, 731407/10/10RM, 731407/6X2RM, 731407/7, 731608/10/10, 731608/10/10RM, 731608/6, 731608/7, 731608/7X2RM, 731608/8/10, 731608/8/10RM, 731809/6, 732010/6, 732412/6, 7330303BL, 7330323BL, 7330343BL, 7330363BL, 7330383BL

Cardiovascular Devices

2

Yes

Nationwide Distribution including the states of : 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, WA, WI and WV.

Gelweave (TM) Vascular Prostheses || Manufactured by - VASCUTEK Ltd || a TERUMO company

Model Name Model NUmber and serial number GEMINI Dual 4535 679 00891 G097, G119, 101-103, 105-107, 109-117, 119-127, 131-144, 146-164, 1025, 2003506, 2003507, 1Z9Z591, 2Z9Z591, 3Z9Z591, 4Z9Z591, GY9Z591, HY9Z591, JY9Z591 GEMINI 16 Power 4535 679 58961 1002, 1004-1008, 1010-1015, 1017-1028, 1030-1034, 1035R, 1036A, 1037-1046, 101R, 1023a, G098, MNM4411 GEMINI GXL (6, 10, 16, and 16 Mobile) 4535 679 75691, 4535 679 81871, 4535 679 76581, 4535 679 71891 4001, 4003-4040, 4042-4089, 4091-4123, 4125-4127, 4129-4137, 4139-4143, 7011, 4097A, 4147a GEMINI TF 16 Slice (16, 64, 64 Mobile and 16 Base) 4535 679 83931, 4535 674 47551, 4535 679 94741, 4535 674 41711 7001, 7003-7006, 7008, 7009, 7013-7017, 7022, 7024, 7025, 7027, 7028

Radiology Devices

2

No

Worldwide Distribution - US Distribution to the states of : AL, AZ, CA, CO, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MO, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, WV, and WY., and to the countries of : Canada, Argentina, Australia, Austria, Belgium, Brazil, China, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, Jordan, Luxembourg, Mexico, Netherlands, Poland, Portugal, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey and UK.

GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.

Serial #s:  4034-4100, 4102, 4103, 1041

Radiology Devices

2

No

Worldwide, including USA, Australia, Canada, China, England, Finland, France, Germany, Ireland, Israel, Italy, Japan, Jordan, Korea, Netherlands, Poland, Puerto Rico, Spain, and Taiwan.

Nuclear medicine systems: || Gemini 16, Model 4535 679 28961. || Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691. || Precedence, Model #2169 -3000A, #2169-3001A, #2169-3002A, and 2169-3003A. || PET/CT Computed tomography systems.

83016862101656 00060VAS02 00192VAS04 00282VAS02 00371VAS01 01065VAS01 082416070006 082416130024 212305CATH1 416480INNOVA 516562INNOVA6 516562INNOVA7 604682INNOVA1 604682INNOVA2 718470EP 770HMCCL1 781340IN3 83016102100795 83016242100936 83016802100516 83016802100866 83016802100916 83016802101197 83016862101656 83016862101916 858554INNOVA2 A4166952 A5164510 cee15663 HU1205VA01 M2068110 M2569315 M4198195 YV0061 YV0071

Radiology Devices

2

No

Worldwide Distribution: USA states including-AZ,CA,CO,DE,FL,GA,IL,IN, MD,MN,MO,NJ,NV,NY,OH,OK,OR,PA,SC,SD,TX, UT, VA,WA,WI, and countries of Canada, Belgium, China, Czech Republic, Finland, France, Germany, Hungary, India, Isreal, Italy, Japan, Korea, New Zealand, Norway, Russia, Spain, and United Kingdom.

GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular)

80140841 850060707 3016094100 3027444100 4134474100 5094744100 5135844100 5417684100 6309784100 7028804100 00171VAS01 00490VAS02 082406120016 082416130020 10091VAS01 190020RX09 201541SP1 251435I12 309672M4100 314569SJRM12 330489SPEC9 360754INNOVA 386HPOS1 412623LAB1 412623LAB3 414328INN4100 419696LAB1 530888ANG206 605333RM10 608263XMR 610954INNOVA41 617525IN1 617636IN1 630275G41 719560INN41 727791INNOVA 803256SP 804594ANGIO 804764CATH3 812238UN41 813615CL10 816943SP1 817433HSW4100 843577CL2 845368RM10 904202SP1 904BSSP 915577SP1 952993INNOVA2 970247INNOVA 972335LIB 972566INNOVA3 A5605732 COR359867 IL1043VA01 N4192927 NO1015VA04 R4211476 RU1106VA02 UC1129XR33 XF0151 XF0153 XF0154 XF0155 XF0200 YV0001 YV0002 YV0004 YV0006 YV0007

Radiology Devices

2

No

Worldwide Distribution: USA states including-AZ,CA,CO,DE,FL,GA,IL,IN, MD,MN,MO,NJ,NV,NY,OH,OK,OR,PA,SC,SD,TX, UT, VA,WA,WI, and countries of Canada, Belgium, China, Czech Republic, Finland, France, Germany, Hungary, India, Isreal, Italy, Japan, Korea, New Zealand, Norway, Russia, Spain, and United Kingdom.

GE Healthcare Innova 4100/4100 IQ. Digital Fluoroscopic Imaging System (Vascular Angiography System)