Events

LATITUDE Communicator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Boston Scientific CRM Corp 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
    53083
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0180-2010
  • 사례 시작날짜
    2009-08-07
  • 사례 출판 날짜
    2009-11-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-12-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84609
  • 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
    Implantable cardioverter defibrillator - Product Code LWS
  • 원인
    The l atitude¿ communicator (model 6481) for a patient may not have been able to receive measurements from their weight scale or blood pressure monitor afer initial setup. the issue has been resolved. if any patient weight or blood pressure readings are stored in the patient's sensor, they will be uploaded to latitude after the patient's communicator calls in to boston scientific's servers. it.
  • 조치
    Boston Scientific used phone calls as the delivery method for these communications. The communication began August 6, 2009 for the original 6 patients affected. Notifications via phone calls to additional patients affected began on August 17, 2009. Direct questions about the recall to the LATITUDE Customer Service by calling 1-651-582-4000.

Device

LATITUDE Communicator
  • 모델명 / 제조번호(시리얼번호)
    SERIAL NUMBERS:  029251, 064452, 059718, 064001, 056441, 059851, 070188, 072291, 312706, 305339, 312762, 004610, 024762, 049668, 061205, 067781, 051788, 056069, 068447, 069808, 008653, 068085, 057090, 023576, 028974, 017638, 603254, 064457, 069473, 069902, 071065, 072021, 073621, 073837, 312707, 605519,  603234, 603788, 072396, 059662, 056346, 301645, 312781, 307327, 067067,  055853, 060274, 605304, 305344, 302301, 605981, 009271, 056500, 300895,  602642, 030830, 301117, 055001, 049660, 047455, 056923, 309556, 044034,  063667, 005931, 067765, 063012, 050130, 051267, 055558, 060325, 060973,  063034, 306808, 306852, 309355, 041156, 062922, 063064, 061177, 300499,  039398, 039401, 039403, 060619, 065476, 058913, 056802, 073812  024833, 073560, 606104, 606288, 606604, 606826, 607180 608231 and 607180.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution -- AZ, AR, CA, CT, FL, GA, IL, IN, MA, MO, NV, NJ, NY, OH, OR, PA, SC, TX, UT, VA and WA.
  • 제품 설명
    Guidant LATITUDE¿ Communicator, model 6481, Boston Scientific 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. The LATITUDE¿ Patient Management system enables physicians to periodically monitor both patient and device status remotely. || The LATITUDE¿ Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database.
  • Manufacturer
    Boston Scientific CRM Corp

Manufacturer

Boston Scientific CRM Corp
  • 제조사 주소
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA