Device Recall e.cam Emission Computed Tomography Systems

  • 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
  • 1 Event

제조사

  • 제조사 주소
    Siemens Medical Solutions USA, Inc., 2501 Barrington Rd, Hoffman Estates IL 60195-2061
  • 제조사 모회사 (2017)
  • Source
    USFDA