Events

Device Recall Pinnacle3 Radiation Therapy Planning (RTP) 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
    67623
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1312-2014
  • 사례 시작날짜
    2014-02-11
  • 사례 출판 날짜
    2014-03-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-11-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125856
  • 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,planning,radiation therapy treatment - Product Code MUJ
  • 원인
    Philips medical systems have recently determined that a software nonconformance can cause incorrect beam geometry. this issue affects pinnacle3 radiation therapy planning (rtp) system, software version 9.0 manufactured from 09/29/09 to 12/01/2013.
  • 조치
    Philips Healthcare sent an Urgent Field Safety Notice dated February 10, 2014, to all affected consignees. The letter included the Problem Description, Hazard Involved, How to Identify Affected Products, Action to be taken by Customer /User, Actions Planned by Philips and Further Information and Support. Consignees were instructed to review the following information with all members of their staff who need to be aware of the contents of this communication including clinics within their institution that are remotely connected to their Pinnacle Server. Customers were questions were instructed to contact their Philips representative. For customers in North America please contact Customer Care Solutions Center at 1-800-722-9377. For all other countries their local Philips Healthcare Office should be contacted. For questions regarding this recall call 1-800-722-9377.

Device

Device Recall Pinnacle3 Radiation Therapy Planning (RTP) System
  • 모델명 / 제조번호(시리얼번호)
    System Code Serial Number DC040898989 DC120785335 DC040801181 DC020893846 DC020893848 DC030936872 DC030938113 DC030938457 DC070948475 DC070948476 DC100956827 DC120961879 DC011064963 DC090775316 DC021070642 DC061086404 DC091095147 DC060767368 DC010887574 DC110782289 DC120787279 DC061132521 DC061132519 DC081138659 DC081138643 DC081139521 DC081139520 1755367 DC080815579 DC070813153  1685358 1134FMM0UW DC090777023 15 DC030936391 ¿15 1708792 1708999 0841BD200F 3/1133FMM0C2 DC110781164 DC060764615 DC060764372 0908QAC00B 0926QAD063 0925QAD076 1666738 0925QAD09E 1029QAD07C 1678826 1684436 0926QAC016 1029QAD06F 0926QAC01C 1714167 1049FMMOGP 1113FMMORB 1113FMMORL 1688542 1688675 1691300 1691303  1694794   1696697 1699759 1699760 1700756 1699761 1699762 1701404 1701389 1715642 1704521 1708407 1709924 1710887 36 1734189 1721212 1723472 1723474 1722542 1730747 1722550 1723491 1730850 1730848 1730746 1737467 1730852 1732235 1732294 1734761 1735978 1736604 1737853 1734675 1738571 1737480 1741347 1746235 1740700 1747900   1745450 1751925 1753082 1753079 1753777 1759510 1759731 1757173 1762113         1665097 1659082 1657556 1659148 1655919 1657364 1657112 1657781 1657783 1657782 1659128 1659129 1685591 1685365 1685354 1685589 1700520 1685685 1685608 1685590 1685604 1702674 1718378 DC051081744 1685357 1700519 1700649 1707577 1706939 1707985 1724442 1724444 58 1746975 1734748 1 5 12 2 3 1753818 1754275 1759838 10 DC090775322 DC090776030 DC120787277 DC020893856 DC070811143 DC070812912 DC050802592 DC050802591 DC050802954 DC030895175 DC050802595 DC121008240 DC070899024  DC030895174 DC030895490 DC020893296 DC090818684 DC090819874 DC030936392 DC090816435 DC120830822 DC120830821 21DC041125223 DC030937243 DC040939540 DC040941365 DC050943690 DC100820417 1661883 1657952 1658310 1657202 DC050802593 70 DC100955993 1663161 1662399 1662400 80 DC031121325 1663005 1675295 1675300 1675298 1675304 1672877 1675302 1676359 1702701 1685603 1685516 1685512 DC040941365 1685511 1702616 1702222 1702214 DC060945180 1702617 1702404 1707900 1703883 1712072 42 DC010888950 DC080815621 1733193 1739388 1747986 64 7 DC120787277 70 1757043 1759357 11 17 18 16 1760294 1706 DC120830823 DC081139519 1721959 DC031265726 0348AD10B2 R04040895 DC070767345 1672974 1672975 1686434 1686030 1686031 1729012 1672728 1672727 1676927 1662142 1662143 1661886 DC030937241 1728902 DC041125240 DC041125238 DC041126664 DC031121220 DC031121222 DC081138661 DC081138641 DC041125220 DC041125219 DC081141501 1655103 DC080814334 1660398 1663463 1655871 1672722 1685372 1684595 1685684 1686444 1686843 1685151 1685153 1689400 1689399 1689398 1689397 1699843 1693119 1695735 1695076 1705232 1712620 1714936 1714935 1715200 1715201 1715594 1715202 1715633 1717086 1717048 1717085 1717357 1717046 1718099 1719459 1719458 1724484 1729907 1729070 1729905 1729069 1732241 1734674 1734673 1734669 1739860 1739861 1739857 1739859 1741338 1739858 1741342 1741344 1741343 1743873 1745453 1747063 1746234 1749837 1749839 1749414 1750242 1753184 1753709 1753100 1754350 1756162 1755861 1757471 1758045 1757118 1758046 1757120 1760848 1760880 1758402 1759193 1759517 1759516 1759839 1762237 1762269 1762616 1762239 DC030937733 DC051081314 1682253 1682365 DC011065765 DC010890602  68 129  DC110958920 0916QBD072 1049FMMOKC DC120785330 DC040941223  1728483 1736529 1750826 1789721 1764323  DC120963809 DC101002887 DC121008235 DC081141500 DC030938078 1685359 1728482 DC071136746 DC120829228 DC080951060 1663190 DC120962521 DC021068564 1680604 1739916 1747134   DC061086722 DC061086720 DC071089531 DC09109605 1712628 1728484 1736606 1728485 1736607 1732286 1737613 1745449 1750935 1746951 DC121152678   1741388 DC021260640 DC041268041 DC121297609 DC041314977 DC041316355 DC091287520  1747899 1740030 R02050132 R02070258  DC030935272 DC120830810 DC080951206 153/154 119-124-138 1706680 1711255DC081095143 1725970 DC030896879 45 35 48 1732238 53 57  DC060766193 1564496 1568365 DC060765767 DC090776271 DC080773053 DC100780861 DC010888511 DC010890312 DC090777025 DC090774343 DC100778920 DC120785964 DC110782278 DC060765456 DC120784550 DC120787276 DC120785878 DC010889158 DC120784553 DC010890543 DC010889166 DC010891062 DC120785339 DC040899000 DC040899029 DC030895500 DC040898999 DC120785331 DC040898993 DC050802886 DC050803190 DC040801177 DC070811097 DC080815615 DC030936634 DC080816030 DC090817767 DC090818222 DC090818224 DC030938459 DC090816436 DC120829223 DC120827455 DC120827461 DC090816441 DC010931565 1658348 DC010932251 DC020934230 DC030937732 DC110827117 DC030936722 DC030937739 DC030937737 DC030937736 DC120829220  DC040939548  101-SUN4140 DC060944078 DC070948461 DC070947661 DC070947876 DC080950539 DC070948473 DC080950941 DC070948240 DC080950940 DC080951056 DC090952438 DC090954301 DC090776261 1656592 0926QAC049 1656676 1657786 1658309 1658390 1658715 1667078 1660498 1666605 1668175 1671553 0924QAC004 1666604 1673118 150 0926QAC095 1668195 1676981                                  0925QAD078   1679825 1680992   0951QAD016   1679199   1686029  0925QAD092    1686601 1686705 1686330 1686331 1686837 1686706  1681818                1693824                       DC071088185                                  1693110                                                   1696775                                                          1702223                                 34                                               75                                                                                                       1113FMMOR2       1729908                   92 1743790     103       1117FMM034 1745451  8
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including US: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and Internationally to AUSTRALIA, AUSTRIA. BELGIUM, CANDA, CHINA, DENMARK, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, IRELAND, ITALY, JAPAN, LUXEMBOURG, MALAYSIA, MEXICO, MONTENEGRO, NETHERLANDS, NEW ZEALAND, OMAN, RUSSIA, SOUTH ARICA, SOUTH KOREA. SPAIN,. SWITZERLAND, TAIWAN, THAILAND, TURKEY, EMIRATES, UNITED KINGDOM. .
  • 제품 설명
    Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.
  • Manufacturer
    Philips Medical Systems (Cleveland), Inc.

Manufacturer

Philips Medical Systems (Cleveland), Inc.
  • 제조사 주소
    Philips Medical Systems (Cleveland), Inc., 5520 Nobel Dr Ste 125, Fitchburg WI 53711-4948
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA