Device Recall e.cam

  • 모델명 / 제조번호(시리얼번호)
    All e.cam towers, serial numbers 00013 through 08543, utilizing e.soft, ICON-S and duet acquisition systems, and e.soft and ICON-S COIN systems.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, United Arab Emirates, Argentina, Austria, Australia, Bosnia, Barbados, Bangladesh, Belgium, Bolivia, Brazil, Camaroon, Canada, Chile, China, Colombia, Republic of Congo, Czech Republic, Denmark, Dominican Republic, El Salvador, Equador, Egypt, France, Finland, Germany, Great Britain, Georgia, Greece, Hong Kong, Honduras, Ireland, Israel, India, Italy, Iraq, Jordan, Japan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Mexico, Morocco, Madagascar, Myanmar, Mauritius, Malaysia, Niger, Norway, New Zealand, Oman, Peru, Philippines, Pakistan, Poland, Potugal, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, Uzbekistan, South Africa and the Netherlands.
  • 제품 설명
    e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., || Nuclear Medicine Group, Hoffman Estates, IL 60195-5203
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Siemens Medical Solutions USA, Inc., 2501 N. Barrington Road, Hoffman Estates IL 60195-5203
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 3 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    e.cam systems that were refurbished from 04/06/15 to 10/06/15. Material number 10151531, serial number 70004; Material number 10151532 serial numbers 70038, 70040, 70041, 70042, 70043, 70044, 70039, 70045, and 70046.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of Florida, New York, Indiana, Maryland, South Dakota, Missouri, Tennessee, and Georgia, and the countries of Australia and India.
  • 제품 설명
    The e.cam Dual Signature Gamma Camera 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.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Material number 4380213, serial numbers 1018 and 3020;  material number 4380221, serial numbers 0009, 1039, 1047, 1056, 1075, 1094, 1099, 1109, 1137, 1166, 1181 and 1190;  material number 5227397, serial number 1136;  material number 5242826, serial numbers 1005, 1024, 1060, 1065, 1070, 1071, 2046, 2050, 2053, 2059, 2070, 2071, 2111, 2114, 3005, 3007, 3019, 3060, 3092, 3098, 3122, 3124, 4024, 4027, 4035, 4039, 4042, 4044, 4060, 4067 and 4075;  material number 5977066, serial numbers 4092, 4165, 5030, 5048 and 5103;  material number 5977074, serial number 5031;  material number 5984005, serial number 7006;  material number 5989079, serial numbers 7538, 8003, 8009, 8031, 8046, 8097, 8527, 8546, 8652, 8665, 8694, 8730, 8744, 8764 and 08501/7823920;  Material number 5989087, serial numbers 7503, 8018, 8514 and 8542;  material number 5991109, serial numbers 5564, 5649,7009, 7017 and 7038;  material number 5991117, serial number 4005;  material number 5992099, serial numbers 5154, 5157 and 5502;  material number 7324143, serial number 0573;  material number 7760809, serial number 8502;  material number 7760932, serial numbers 8528, 8575 and 9024;  material number 7823920, serial number 8508;  material number 7823946, serial numbers 9088, 9092, 9112, 9128, 9161, 9171, 9203, 9210, 9237, 10036, 10038, 10095, 10097, 10137, 10161, 10239, 10306, 11017, 11040, 11071, 11145, 11186, 11195, 11226, 11291, 11298, 11411, 11419, 11477, 11496, 11505, 11653, 11660, 11762 and 11789; material number 7823953, serial numbers 9024, 11057 and 11139;  material number 7823979, serial number 9013;  material number 10151531, serial numbers 1021 and 1022; and  material number 10151532, serial numbers 1027, 1049, 1134, 1137, 1138, 1317, 1321, 1343 and 1345.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution, US (Nationwide) and the countries of Australia, Belgium, Canada, China, France, Germany, Italy, Japan, Republic of Korea, Mexico, Netherlands, Portugal, Spain, Taiwan and the United Kingdom.
  • 제품 설명
    e.cam Emission Computed Tomography Systems. Siemens e.cam Emission Imaging Computed Tomography Systems is used for all common nuclear medicine procedures.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    part number 43 66 618 (right) and 43 81 088 (left), serial numbers 00001 to 04031
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, Guam, Argentina, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Great Britain, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Latvia, Lebanon, Mauritius, Mexico, Myanmar, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Turkey and United Arab Emirates.
  • 제품 설명
    Siemens Medical Solutions E.CAM Patient Handling System (PHS) Field of View (FOV) indicator bars; a component of the E.CAM Emission Computed Tomography System; part number 43 66 618 (right) and 43 81 088 (left).
  • Manufacturer