Events

proSA Tool Set (Model: FV92T) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Aesculap Implant Systems LLC 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
    79093
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0809-2018
  • 사례 시작날짜
    2017-09-21
  • 사례 상황
    Completed
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161324
  • 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
    Shunt, central nervous system and components - Product Code JXG
  • 원인
    A prosa adjusting pin used to adjust the prosa adjustable shunt system does not set the correct valve opening pressure.
  • 조치
    Aesculap sent an Urgent Medical Device Recall Notification letter dated September 21, 2017. 1. Review the Urgent Medical Device Recall Notification Letter in its entirety and ensure that all users in your organization and other concerned persons are informed about this recall and immediately quarantine the unit. 2. Determine the current inventory of the affected lot(s) within your facility. Please quarantine the product and do use. Do not destroy any affected product. A Sales Representative will come to your facility and remove the affected sets and provide you replacements. 3. Please complete the attached Product Recall Acknowledgement Response Form on the next page of this letter and record the total number of units in your possession. If you have no inventory remaining, please enter zero (0) on the form and reason WHY. The Sales Representative will return the form along with the affected product to: 4.The Sales Representative will contact Customer Service to order replacements sets and get a Recall RGR number to return the affected sets. For further questions, please call (610) 984-9414 Ext. 5414

Device

proSA Tool Set (Model: FV92T)
  • 모델명 / 제조번호(시리얼번호)
    Batch #20034364 and #20034751
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Distribution to PA.
  • 제품 설명
    proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System || Shunt, central nervous system and components
  • Manufacturer
    Aesculap Implant Systems LLC

Manufacturer

Aesculap Implant Systems LLC
  • 제조사 주소
    Aesculap Implant Systems LLC, 3773 Corporate Pkwy, Center Valley PA 18034-8217
  • 제조사 모회사 (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA