e.cam -emission computed tomography system Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.

Recall details

Manufacturer

Siemens Medical Solutions USA, Inc.

Distributor

Worldwide Distribution: US (nationwide) including states of: AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, MA, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY and Puerto Rico; and countries of: Algeria , Angola , Argentina , Australia , Austria , Azerbaijan , Bahrain , Bangladesh , Belarus , Belgium , Bolivia , Bosnia Herzeg. , Brazil , Bulgaria , Cameroon , Canada , Chile , Colombia , Costa Rica , Croatia , Cuba , Czech Republic , Dem. Rep. Congo , Denmark , Dominican Rep. , Ecuador , Egypt , El Salvador , Finland , France , Georgia , Germany , Ghana , Greece , Guam , Honduras , Hong Kong , India , Indonesia , Iran , Iraq , Ireland , Israel , Italy , Jamaica , Japan , Jordan , Kazakhstan , Kosovo , Kuwait , Latvia , Lebanon , Luxembourg , Macedonia , Malaysia , Mauritius , Mexico , Morocco , Myanmar , Nepal , Netherlands , New Zealand , Niger , Nigeria , Norway , Oman , P.R. China , Pakistan , Palestinian Ter , Peru , Philippines , Poland , Portugal , Qatar , Rep. of Yemen , Republic Korea , Romania , Russian Fed. , Saudi Arabia , Serbia , Singapore , Slovakia , Slovenia , South Africa , Spain , Sri Lanka , Sweden , Switzerland , Syria , Taiwan , Thailand , Trinidad,Tobago , Tunisia , Turkey , Uganda , Ukraine , United Arab Emirates , United Kingdom , Uruguay , Uzbekistan , and Vietnam.

Lot

1) E.CAM DCR Duet Head, A (e.soft); Serial Numbers: 7090 , 7501 , 7502 , 8001 , 8002 , 8003 , 8004 , 8501 , 8502 , 8506 , 8507 ; 2) E.CAM DCR Gantry Dual Head, Bl Serial Numbers: 3097 , 8502 , 8507 , 8508 , 8509 , 8510 , 8511 , 8514 , 8516 , 8521 , 8522 , 9821 , 71101 ; 3) E.CAM DCR Gantry Single Head; Serial Numbers: 5045 , 7501 , 7502 , 7503 , 7504 , 7505 , 7506 , 7507 , 7508 , 7509 , 7510 , 7511 , 7512 , 8001 , 8002 , 8003 , 8004 , 8005 , 8006 , 8007 , 8008 , 8009 , 8010 , 8011 , 8012 , 8013 , 8014 , 8015 , 8016 , 8017 , 8018 , 8019 , 8020 , 8021 , 8022 , 8023 , 8024 , 8025 , 8026 , 8027 , 8028 , 8029 , 8030 , 8031 , 8032 , 8033 , 8501 , 8502 , 8503 , 8504 , 8505 , 8506 , 8507 , 8508 , 8509 , 8510 , 8511 , 8512 , 8513 , 8514 , 8516 , 8517 , 8518 , 8519 , 8520 , 8521 , 8522 , 8523 , 8524 , 8525 , 8526 , 8527 , 8528 , 8530 , 8532 , 8533 , 8534 , 8535 , 8536 , 8537 , 8538 , 8539 , 8540 , 8541 , 8542 , 8543 , 8544 , 8545 , 8546 , 8547 , 8548 , 8549 , 8550 , 8551 , 8552 , 8553 , 8554 , 8555 , 8556 ; 4) E.CAM DCR Gantry Single Head, B; Serial Numbers: 2011 , 5504 , 7510 , 8501 , 8502 , 8503 , 8505 , 8507 , 8508 , 8509 , 8511 , 8512 , 8513 , 8514 , 8516 , 8517 , 8518 , 8519 , 8520 , 8521 , 8501* ; 5) E.CAM Duet Head (e.soft); Serial Numbers: 2 , 3 , 6001 , 6003 , 6005 , 6006 , 6007 , 6009 , 6010 , 7001 , 7004 , 7005 , 7006 , 7502 , 7503 , 7505 , 7507 , 7508 ; 6) E.CAM extended Gantry dual head v3; Serial Numbers: 1001 , 5039 , 5161 , 5501 , 5504 , 5506 , 5507 , 5508 , 5509 , 5510 , 5511 , 5512 , 5513 , 5514 , 5515 , 5516 , 5517 , 5519 , 5520 , 5521 , 5522 , 5524 , 5525 , 5526 , 5528 , 5529 , 5530 , 5532 , 5533 , 5534 , 5535 , 5536 , 5538 , 5539 , 5540 , 5541 , 5542 , 5543 , 5544 , 5545 , 5546 , 5547 , 5548 , 5549 , 5550 , 5553 , 5554 , 5555 , 5556 , 5557 , 5558 , 5560 , 5561 , 5563 , 5564 , 5565 , 5566 , 5567 , 5568 , 5570 , 5571 , 5572 , 5576 , 5578 , 5579 , 5580 , 5582 , 5583 , 5584 , 5585 , 5586 , 5587 , 5588 , 5589 , 5590 , 5591 , 5592 , 5593 , 5594 , 5595 , 5596 , 5597 , 5598 , 5599 , 5600 , 5601 , 5602 , 5603 , 5604 , 5605 , 5606 , 5607 , 5608 , 5609 , 5610 , 5611 , 5612 , 5613 , 5614 , 5615 , 5616 , 5617 , 5618 , 5619 , 5620 , 5621 , 5622 , 5623 , 5624 , 5625 , 5626 , 5628 , 5629 , 5631 , 5632 , 5633 , 5634 , 5635 , 5636 , 5637 , 5638 , 5639 , 5640 , 5641 , 5642 , 5643 , 5644 , 5645 , 5646 , 5647 , 5649 , 5650 , 5652 , 5655 , 5658 , 7002 , 7003 , 7004 , 7005 , 7006 , 7007 , 7008 , 7009 , 7010 , 7011 , 7012 , 7013 , 7014 , 7016 , 7017 , 7018 , 7019 , 7020 , 7021 , 7022 , 7023 , 7024 , 7025 , 7026 , 7027 , 7028 , 7029 , 7030 , 7031 , 7032 , 7033 , 7034 , 7036 , 7037 , 7038 , 7039 , 7040 , 7041 , 7042 , 7043 , 7044 , 7045 , 7046 , 7047 , 7048 , 7049 , 7050 , 7051 , 7052 , 7053 , 7054 , 7055 , 7056 , 7057 , 7058 , 7059 , 7060 , 7061 , 7062 , 7063 , 7065 , 7067 , 7068 , 7069 , 7070 , 7071 , 7072 , 7073 , 7074 , 7075 , 7076 , 7077 , 7078 , 7079 , 7080 , 7081 , 7082 , 7083 , 7084 , 7085 , 7086 , 7088 , 7090 , 7091 , 7092 , 7093 , 7094 , 7095 , 7096 , 7097 , 7097 , 7098 , 7099 , 7101 , 7103 , 7104 , 7105 , 7109 , 7110 , 7111 , 7112 , 7114 , 7115 , 7116 , 7117 , 7118 , 7119 , 7120 , 7121 , 7122 , 7123 , 7124 , 7125 , 7126 , 7127 , 7129 , 7130 , 7178 , 7179 , 7501 , 7502 , 7504 , 7505 , 7506 , 7507 , 7508 , 7509 , 7510 , 7511 , 7512 , 7513 , 7514 , 7515 , 7516 , 7518 , 7521 , 7522 , 7523 , 7524 , 7526 , 7528 , 7529 , 7530 , 7531 , 7532 , 7533 , 7534 , 7535 , 7536 , 7537 , 7538 , 7539 , 7540 , 7541 , 7542 , 7543 , 7544 , 7545 , 7546 , 7549 , 7550 , 7552 , 7553 , 7554 , 7556 ,

Risk classification

Class II

Area (FDA)

device

Country

United States