Events

Device Recall Image1 SPIES XLINK Camera Control Unit (CCU) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Karl Storz Endoscopy 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
    74515
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2134-2016
  • 사례 시작날짜
    2016-06-20
  • 사례 출판 날짜
    2016-07-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-01-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147810
  • 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
    Endoscopic video imaging system/component, gastroenterology-urology - Product Code FET
  • 원인
    Potential electrical interference issue when the image1 spies x-link and image1 spies d1 camera head are used in conjunction with the dci video mediastinocope and an electro-surgery generator (esg).
  • 조치
    KARL STORZ sent an Customer Notification letter dated June 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. KARL STORZ has become aware become aware of a potential electrical interference issue when the lmage1 SPIES X-LINK and lmage1 SPIES D1 camera head are used in conjunction with the DCI Video Mediastinoscope and an electro-surgery generator (ESG). Customers are instructed to complete the attached acknowledgement Form and to return it to KARL STORZ. Customers with questions are instructed to contact Technical Support Dept. at (800) 421-0837, press 2, and then press 1.

Device

Device Recall Image1 SPIES XLINK Camera Control Unit (CCU)
  • 모델명 / 제조번호(시리얼번호)
    NT743473-P NT743472-P NT742840-P XU738911-P YU741045-P XU738248-P WU737260-P PV715203-P PV715207-P NT742829-P XU738899-P WU737275-P YV724235-P WU737269-P WU737268-P VU736411-P XU738901-P XU738910-P ZU742677-P YU741050-P VU736405-P TU733422-P TU733419-P SU733063-P VU736390-P VU736386-P UU734392-P RV716122-P OT744400-P NT743287-P OT744395-P NU727551-P NU727552-P NU727706-P TU734218-P TU734217-P NT742846-P YU741046-P OU728667-P TU733735-P VU736388-P NT742848-P NT742838-P OU728672-P OU728427-P WU737813-P OU729135-P OU728431-P OU728430-P WU737805-P ZU742670-P ZU742671-P YU741049-P YU740475-P ZU742681-P RV716116-P SU733055-P SU733057-P SU733059-P SU733060-P TU733418-P TU733420-P TU733421-P TU733423-P TU733424-P TU733425-P TU733427-P WU737810-P XU738914-P YU740004-P YU740471-P YU740479-P YU740480-P YU741036-P NV711744-P PV715216-P OU728670-P NU726430-P OT744399-P OT744389-P OT744386-P YU739999-P YU740003-P YU740005-P UU734395-P YV724443-P YV724442-P YV724440-P YV724438-P YV724245-P
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution to the states of : IL, NM, TX, MD, TN, PA, FL, KY, MO, NY, MN, DC, MA, WI, CT, MI, ID, CO, GA, NJ and AR., and to the countries of : Argentina, Australia, Belgium, Bulgaria, China, Germany, Finland, Great Britain, India, Italy and Japan.
  • 제품 설명
    Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH116 & TH115, and DC1 Video Mediastinoscope
  • Manufacturer
    Karl Storz Endoscopy

Manufacturer

Karl Storz Endoscopy
  • 제조사 주소
    Karl Storz Endoscopy, 2151 E Grand Ave, El Segundo CA 90245-5017
  • 제조사 모회사 (2017)
    Karl Storz SE & Co. KG
  • Source
    USFDA