Events

Device Recall PHILIPS MODEL MX 16slice Computed Tomography Scanners 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
    58209
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2059-2011
  • 사례 시작날짜
    2011-03-10
  • 사례 출판 날짜
    2011-04-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-03-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98678
  • 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
    The philips mx 16-slice ct scanners are subject to recall/field correction due to a problem encountered with the units when using the 'combine viewing' option. the firm determined that inaccurate dimension measurements display when using the combine viewing option. moreover, if the dimension measurements from merged images created using this option are used, there is a potential for applying inac.
  • 조치
    Philips Healthcare issued an 'URGENT- Field Safety Notice MX 16-slice' (dated 3/10/2011) concerning a software issue to customers. The notification informed the firm's users/customers of the potential for inaccurate dimension measurements produced by the MX 16-slice CT scanners when using the Combine Function Viewing Option. Moreover, the letter notified customers of the potential for patient misdiagnosis in the event that inaccurate dimension measurements are used by a physician for reference. The Field Safety Notice described the following: 1) How to identify the affected product; 2) What actions should to be taken by the customers with regard to avoiding the issue -discontinue use of the Combine Viewing Option and instead use the MPR Batch for diagnostic reviews until a planned software upgrade is installed by the recalling firm; and 3) The firm's plans to carry out the installation of a field change order kits to correct the issue. The planned software upgrade is expected to be completed on or before 6 months after the new software is released. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Site ID or follow the prompts).

Device

Device Recall PHILIPS MODEL MX 16slice Computed Tomography Scanners
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers are: P16C080002, P16E080005, P16E080007, P16E080008, P16E080012, P16E080010, P16E090004, P16E090008, P16E090005, P16E080007, P16E080008, P16E080012, P16E080010, P16E090004, P16E090008, P16E090005, P16E090006, P16E090007, P16E090009, P16E090012, P16E090003, P16E090010, P16E090011, P16E090013, P16EM09003, P16EM09004, P16E090002, P16E090014, P16E090015, P16EM08003, P16E090016, P16E090018, P16E090019, P16E090020, P16E090021, P16E090026, EP16E090001, P16E090028, P16E090027, P16E090017, P16EM09002, P16E090024, P16E090025, EP16E090002, EP16E090003, EP16E090004, EP16E090006, EP16E090007, EP16E090008, EP16E090009, P16C090001, EP16E090010, EP16E090011, EP16E090012, EP16E090014, EP16E090015, EP16E100001, EP16E100002, EP16E100004, EP16E100003, EP16E100005, EP16E100006, EP16E100007, EP16E090013, EP16E100008, EP16E100009, EP16E100010, P16C100001, EP16E100011, EP16E100012, EP16E100013, EP16E100014, EP16E100015, EP16E100016, EP16E100017, EP16E100018, EP16E100019, P16C080001, EP16E100020, EP16E100021, EP16E100022, EP16E100023, EP16E100024, EP16E100027, EP16E100026, EP16E100030, EP16E100031, EP16E100029, P16C100003, EP16E100025, EP16E100028, P16C100002, EP16E100034, EP16E100033, EP16E100032, EP16E100035, EP16E100036, EP16E100037, P16E100002, P16C100004, EP16E100039, EP16E100038, EP16E100042, EP16E100043, EP16E100041, EP16E100044, EP16E100046, EP16E100045, EP16E100048, EP16E100047, EP16E100051, EP16E100049, EP16E100050, EP16E100053, EP16E100052, EP16E100054, EP16E100056, EP16E100055, P16C100005, EP16E100057, EP16E100058, EP16E100059, EP16E100060, EP16E100061, EP16E100062, EP16E100063, P16C100007, EP16E100067, EP16ER100003, EP16ER100004, EP16ER100005, EP16E100070, EP16E100069, EP16E100071, EP16E100072, EP16E100073, EP16E100074, EP16E100078, EP16E100075, EP16E100076, EP16E100077, EP16E100079, EP16E100080, EP16E100082, EP16E100081, EP16E100083, EP16E100084, P16C100008, P16C100009, EP16E100085, EP16E100086, EP16E100087, P16C100010, EP16E100088, EP16E100089, EP16E100090, EP16E100091, EP16E100093, EP16E100094, EP16E100092, P16C100014, P16C100015, EP16E100095, P16C100011, EP16E100096, EP16E100097, EP16E100098, P16C100017, EP16E100099, EP16E100100, EP16E100101, EP16E100102, P16C100013, EP16E100103, EP16E100104, EP16E100105, EP16E100106, EP16E100109, EP16E100107, P16C100012, EP16E100108, EP16E100111, EP16E100110, P16C100018, EP16E100112, EP16ER100008, EP16ER100007, EP16E100113, EP16E110003, EP16E110001, EP16E110002, EP16E110004, and EP16E110005.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States (AL, AR, CA, FL, GA, IL, IN, MS, NJ, NV, NY, OH, PA, SC and TX) including Puerto Rico and countries of Albania, Argentina, Australia, Belgium Brazil, Chile, Columbia, Dominican Republic, Ecuador, Germany, Greece, India, Indonesia, Italy, japan, Kenya, Lebanon, Malawi, The Netherlands, Philippines, Poland, Romania, Saudi Arabia, South Africa, Spain, Switzerland, Turkey, Uganda, United Arab Emirates and Venezuela
  • 제품 설명
    MX 16-slice Computed Tomography Scanners, equipped with Software Version 1.1.1. Model #E989605657371. || The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

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