Events

Device Recall Philips BV Pulsera 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems North America Co. Phillips 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
    57611
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1605-2011
  • 사례 시작날짜
    2010-12-14
  • 사례 출판 날짜
    2011-03-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96794
  • 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
    Mobile X-Ray System - Product Code IXL
  • 원인
    The fixing strap of the belt holding the cbx laser to the image intensifier may be detached during a procedure when used with the bv libra and the bv pulsera/endura systems.
  • 조치
    On 01/06/11, Philips sent an URGENT Device Correction Notice, dated 01/05/2011, to their consignees. The consignees were informed that the fixing strap of the Laser Aiming Device Image Intensifier may inadvertently detach when used with BV Libra, BV Endura Rel. 2, and BV Pulsera Rel 2.3 Mobile X-Ray systems. Specifically the draw latch of the fixing strap holding the CBX Laser to the Image Intensified can be accidentally released during a procedure when used with the above Mobile X-Ray systems. While waiting for Philips to implement their corrective action, the consignees are advised to fix the closed latch body of the draw latch to the metal band using a Tie Wrap. Without securing the latch with a Tie Wrap, the device should not be used. The consignees can contact Philips Call Center at 1-800-722-9377, select 5, and reference FCO 71800035 with any questions about this recall.

Device

Device Recall Philips BV Pulsera
  • 모델명 / 제조번호(시리얼번호)
    Site Numbers:  541558, 543462, 543465, 546516, 546531, 546786, 548972, 549275, 549674, 551422, 551444, 551536, 552246, 552452, 552642, 553590, 554473, 554778, 555172, 555727, 555734, 556193, 556206, 556207, 556887, 556920, 557242, 557528, 557570, 557711, 558004, 558232, 558418, 558531, 558632, 558698, 558867, 558925, 558966, 558967, 559322, 559533, 559655, 559658, 559679, 718093, 718101, 41443721, 41444449, 41444577, 41445484, 41445534, 41445599, 41445718, 41445794, 41445895, 41446243, 41446285, 41566245, 41577033, 41587498, 41611719, 41620935, 41620966, 41621991, 41630562, 41645797, 41657683, 41725782, 41748088, 41748089, 41757996, 41780384, 41781354, 41793882, 41885442, 41898013, 41936644, 41938193, 41957602, 41980506, 41986348, 41986353, 41986793, 41987067, 42028669, 42057341, 42182116, 42451705, 42454796, 42474222, 42474223, 42474572, 42474590, 42474663, 42474665, 42474666, 42485796, 42573106, 42573206, 42573399, 42602299, 42616997, 42624941, 42638526, 42657622, 42672459, 42673598, 42677649, 42678321, 42678333, 42678370, 42792818, 42792938, 42859118, 42861795, 42865605, 42869019, 42878225, 42878264, 42878386, 42878440, 42879150, 42879151, 42879230, 42879779, 42891959, 42943097, 42967767, 42968938, 43121942, 43188697, 43246451, 43443832, 43444160, 43444432, 43627105, 43670825, 43708894, 43721186, 43721760, 43721768, 43901634, 43901635, 43972187, 44038499, 44066851, 44235029, 44267704, 44280799, 44330157, 44331403, 44468017, 44489300, 44618133, 45003856, 45030262, 45142308, 45147848, 45147983, 45149689, 45167263, 45168542, 45170408, 45298834, 45303038, 45354311, 45419191, 45428659, 45428664, 45567407, 45586672, 45613075, 45632498, 45641330, 45641331, 47171051, 47349848, 47403000, 47405559, 47420473, 47420474, 47480674, 47539379, 49025829, 49316313, 49368038, 49521186, 49580142, 49753197, 49755484, 49755485, 49875328, 50093136, 50103844, 50110372, 50230731, 50264654, 50305994, 50467164, 50498513, 50829949, 50829955, 51232777, 51240352, 51240364, 51240371, 51240383, 51240386, 51674316, 51702012, 51834968, 51836826, and 51836851.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Washington, DC.
  • 제품 설명
    Philips BV Pulsera, Rel. 2.3, 718095. || Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • 제조사 주소
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA