Events

Device Recall Symbia T Series SPECT System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Medical Solutions USA, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    51483
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1649-2009
  • 사례 시작날짜
    2009-03-11
  • 사례 출판 날짜
    2009-07-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-09-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80495
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Single-Photon Emission Computed Tomography - Product Code KPS
  • 원인
    Patient injury can occur when the patient is lying on the patient bed and the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow. detector motions required for this change can cause collision with the patient or pallet if it is in brain scan position, i.E. the patient or pallet is into the field of view.
  • 조치
    Siemens sent Urgent Field Correction Recall letters dated 1/20/09 to all users of the Symbia S and Symbia T Systems. The accounts were informed of the potential injury to patients while lying on the patient bed and the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow. The customers were advised to perform all necessary collimator changes before the patient is positioned on the patient bed, and to examine each of their workflows that include a Tomo Acquisition activity and make sure the Auto Collimator Change check box on the Camera Parameters Tab is not checked. They also were advised that a Siemens Customer Service Representative would contact them within 60 days to schedule a corrective software upgrade free of charge. Any questions were directed to contact Siemens Medical Solutions USA, Inc. at 1-800-767-2313 (USA) for assistance. The accounts were requested to complete the Mandatory Fax-Back Form acknowledging receipt and understanding of the letter.

Device

Device Recall Symbia T Series SPECT System
  • 모델명 / 제조번호(시리얼번호)
    Part number 8717733, serial numbers 1019, 1020, 1021, 1023, 1041, 1042, 1043, 1052, 1054, 1067, 1072, 1073, 1077, 1090, 1091, 1103, 1106, 1109, 1121, 1125, 1127, 1128, 1135, 1138, 1140, 1147, 1150, 1153, 1157, 1158, 1162, 1163, 1168, 1169, 1170, 1171, 1173, 1174, 1175, 1178, 1180, 1181, 1184, 1187, 1191, 1193, 1194, 1196, 1198, 1199, 1202, 1204, 1208, and 1210;  Part number 10275007, serial numbers 1001, 1006, 1007, 1009, 1011, 1012, 1014, 1015, 1018, 1023, 1026, 1029, 1030, 1032, 1034, 1035, 1038, 1039, 1040, 1041, 1043, 1044, 1053, 1057, 1058, 1059, 1060, 1061, 1064, 1065, 1069, and 1071 Part number 1075008, serial numbers 1002, 1003, 1009, 1010, 1011, 1017, 1018, 1019, 1020, 1023, 1024, 1031, 1035, 1038, 1041, 1047, 1055, 1056, 1057, 1058, 1063, 1065, 1066, 1069, 1071, and 1076;  Part number 10275009, serial numbers 1008, 1013, 1015, 1017, 1019, 1020, 1022, 1024, 1026, 1027, 1028, 1029, 1030, 1032, 1034, 1039, 1040, 1044, 1046, 1047, 1050, 1051, 1054, 1055, and 1056;  Part number 10275010, serial numbers 1001, 1002, 1003, 1004, 1006, 1007, 1008, 1010, 1011, 1012, and 1013
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution, including USA, Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Italy, Japan, Korea, Kuwait, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Sweden and Switzerland.
  • 제품 설명
    Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System;
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

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