Events

Device Recall MX 16Slice CT Scanner System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems (Cleveland) 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
    66237
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0019-2014
  • 사례 시작날짜
    2013-07-22
  • 사례 출판 날짜
    2013-10-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-09-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121811
  • 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
    System, x-ray, tomography, computed - Product Code JAK
  • 원인
    A pinch point at the end of the table top can cause injury.
  • 조치
    Field Safety Notice (FSN 72800601_72800603, will be sent to all US consignees via certified mail. Philips Key Market representatives will distribute the letter internationally. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order.

Device

Device Recall MX 16Slice CT Scanner System
  • 모델명 / 제조번호(시리얼번호)
    Model # 728131  510(k) K083498  Serial #: EP16E090001, EP16E090002, EP16E090003, EP16E090006, EP16E090009, EP16E090010, EP16E090011, EP16E090012, EP16E090013, EP16E090015, EP16E100001, EP16E100004, EP16E100006, EP16E100008, EP16E100010, EP16E100012, EP16E100013, EP16E100016, EP16E100017, EP16E100018, EP16E100019, EP16E100020, EP16E100021, EP16E100022, EP16E100023, EP16E100024, EP16E100025, EP16E100026, EP16E100028, EP16E100029, EP16E100031, EP16E100032, EP16E100033, EP16E100034, EP16E100035, EP16E100037, EP16E100038, EP16E100039, EP16E100041, EP16E100043, EP16E100044, EP16E100045, EP16E100046, EP16E100047, EP16E100049, EP16E100051, EP16E100052, EP16E100055, EP16E100056, EP16E100058, EP16E100059, EP16E100060, EP16E100062, EP16E100063, EP16E100067, EP16E100069, EP16E100070, EP16E100071, EP16E100072, EP16E100073, EP16E100074, EP16E100075, EP16E100076, EP16E100077, EP16E100078, EP16E100079, EP16E100081, EP16E100082, EP16E100083, EP16E100084, EP16E100085, EP16E100086, EP16E100087, EP16E100088, EP16E100090, EP16E100091, EP16E100093, EP16E100094, EP16E100095, EP16E100096, EP16E100100, EP16E100101, EP16E100103, EP16E100104, EP16E100105, EP16E100106, EP16E100107, EP16E100108, EP16E100109, EP16E100110, EP16E100112, EP16E100113, EP16E110003, EP16E110005, EP16E110006, EP16E110009, EP16E110011, EP16E110012, EP16E110013, EP16E110014, EP16E110015, EP16E110017, EP16E110018, EP16E110019, EP16E110020, EP16E110021, EP16E110023, EP16E110024, EP16E110025, EP16E110026, EP16E110029, EP16E110030, EP16E110031, EP16E110035, EP16E110037, EP16E110038, EP16E110042, EP16E110043, EP16E110044, EP16E110045, EP16E110046, EP16E110047, EP16E110048, EP16E110049, EP16E110050, EP16E110051, EP16E110054, EP16E110055, EP16E110056, EP16E110058, EP16E110060, EP16E110063, EP16E110064, EP16E110066, EP16E110067, EP16E110069, EP16E110074, EP16E110075, EP16E110077, EP16E110078, EP16E110080, EP16E110083, EP16E110084, EP16E110085, EP16E110089, EP16E110090, EP16E110091, EP16E110092, EP16E110093, EP16E110095, EP16E110096, EP16E110097, EP16E110099, EP16E110100, EP16E110101, EP16E110102, EP16E110104, EP16E110105, EP16E110106, EP16E110107, EP16E110108, EP16E110109, EP16E110110, EP16E110111, EP16E110117, EP16E110119, EP16E120003, EP16E120004, EP16E120005, EP16E120006, EP16E120008, EP16E120009, EP16E120010, EP16E120011, EP16E120014, EP16E120015, EP16E120016, EP16E120017, EP16E120019, EP16E120021, EP16E120023, EP16E120024, EP16E120025, EP16E120026, EP16E120027, EP16E120029, EP16E120030, EP16E120031, EP16E120032, EP16E120033, EP16E120034, EP16E120035, EP16E120036, EP16E120037, EP16E120040, EP16E120041, EP16E120042, EP16E120043, EP16E120044, EP16E120045, EP16E120046, EP16E120047, EP16E120048, EP16E120050, EP16E120052, EP16E120055, EP16E120056, EP16E120058, EP16E120059, EP16E120060, EP16E120061, EP16E120063, EP16E120065, EP16E120067, EP16E120068, EP16E120070, EP16E120071, EP16E120072, EP16E120074, EP16E120075, EP16E120076, EP16E120078, EP16E120081, EP16E120083, EP16E120089, P16C080001, P16C080002, P16C100001, P16C100002, P16C100003, P16C100004, P16C100005, P16C100007, P16C100008, P16C100009, P16C100010, P16C100011, P16C100012, P16C100013, P16C100014, P16C100015, P16C100017, P16C100018, P16C110001, P16C110002, P16C110003, P16C110004, P16C110005, P16C110006, P16C110007, P16C110008, P16C110011, P16C110012, P16C110013, P16C110014, P16C110015, P16C110016, P16C110017, P16C110018, P16C110019, P16C110020, P16C110021, P16C110022, P16C110023, P16C110024, P16C110025, P16C110026, P16C110027, P16C110028, P16C110029, P16C110030, P16C110031, P16C110032, P16C110033, P16C110034, P16C110035, P16C110036, P16C110037, P16C120001, P16C120002, P16C120003, P16C120006, P16C120007, P16C120008, P16C120009, P16C120011, P16C120012, P16C120014, P16C120016, P16C120017, P16C120018, P16C120019, P16C120020, P16C120021, P16C120022, P16C120023, P16C120024, P16C120025, P16C120026, P16C120027, P16C120029, P16C120030, P16C120032, P16C120033, P16C120036, P16C120038, P16C120039, P16E080007, P16E080008, P16E090002, P16E090003, P16E090004, P16E090007, P16E090008, P16E090012, P16E090013, P16E090014, P16E090015, P16E090016, P16E090018, P16E090019, P16E090027, P16EF80010, P16EM08003, P16EM09002 and P16EM09004.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA including the states of AL, AR, CA, FL, GA, IL, IN, KY, MS, NC, NJ, NV, NY, OH, PA, and VA; and countries of: Albania, Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Cambodia, China, Ghana, Greece, India, Indonesia, Ireland, Italy, Jordan, Latvia, Lebanon, Libya, Lithuania, Malawi, Mexico, Nepal, Netherlands, Oman, Palestine, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, Uganda, Ukraine, Uzbekistan, Venezuela and Vietnam.
  • 제품 설명
    MX 16-Slice CT Scanner System. || Used as a whole-body computed tomography X-Ray system.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • 제조사 주소
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA