Events

BABIX Holder for BuckyDiagnost Xray system 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
    56707
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0021-2011
  • 사례 시작날짜
    2010-09-09
  • 사례 출판 날짜
    2010-10-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-07-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94329
  • 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, stationary - Product Code KPR
  • 원인
    Potential of broken strands in the main steel cable supporting the accessory holder used with buckydiagnost and digitaldiagnost x-ray systems.
  • 조치
    Philips issued URGENT-Device Correction Notice letters dated September 9, 2010 to their consignees identifying the affected products and action to be taken by customers. The letter states that Babix holder used with Philips BuckyDiagnost and DigitalDiagnost X-Ray System - VS Wall Stand Risk of steel cable fracture in the support holder. The consignees are informed that there is a potential of broken strands at the main steel cable within the holder which cannot be recognized by the user. The firm will issue the Field Change Order (FCO) and the Service Engineer will replace the Babix holder. Consignees can call Philips Call Center at 800-722-9377, #5 (then follow prompts) and reference to FCO 70400038 for the BuckyDiagnost X-ray system and FCO 71200046 for the DigitalDiagnost X-ray system.

Device

BABIX Holder for BuckyDiagnost Xray system
  • 모델명 / 제조번호(시리얼번호)
    Devices are identified as Site Numbers: 546607, 48682949, 554660, and 555738.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution in the states of CA, GA, and TN.
  • 제품 설명
    The BABIX holder is an accessory used with the BuckyDiagnost X-ray system. It is used to hold the baby either in a secured or immobilized standing position in front of the X-ray detector during the examination.
  • 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