Double Foot Switch 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ziehm Imaging Inc 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
    60661
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1430-2012
  • 사례 시작날짜
    2011-04-29
  • 사례 출판 날짜
    2012-04-16
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-04-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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, fluoroscopic, image-intensified - Product Code JAA
  • 원인
    On 04/29/2011, ziehm imaging, inc., orlando, fl recalled the double foot switch, type kf 2 1s/1s-med-ap, a component used with ziehm imaging gmbh mobile c-arm due to the potential of unintentional continued activation of fluoroscopic x-ray as the foot switch may not become inactive when the pedal is released.
  • 조치
    Ziehm Imaging, Inc., Orlando, FL sent an Urgent Recall Notice letter dated April 11, 2011, that included a return receipt request, envelope, and a reply questionnaire. to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. They also called consignees. After contact, Ziehm Imaging, Inc. shipped a replacement foot switch with instructions for the customer/end user on how to install the replacement foot switch. If no signed confirmation was received, Ziehm Imaging, Inc. visited the consignee and replaced the foot switch. Customers were asked to fax the completed response form to 866-839-7893.

Device

  • 모델명 / 제조번호(시리얼번호)
    C-Arm Device Model #   Ziehm Vision2 Family; serial numbers: 90209, 90222, 90225, 90227, 90228, 90230, 90245, 902046, 90250, 90251, and 90269.   Ziehm Vision2 FD, Ziehm Vision2 FD Vario 3D serial numbers: 90197, 90241, 90242, 90243, and 90249.   Ziehm Vision R; serial numbers: 10287, 10288, 10289, 10290, 10295, 10297, and 10317.   Ziehm Vision RFD; serial numbers: 20048 and 20049.   Ziehm Solo; serial numbers: 50105, 50138, 50144, 50155, 50156, 50164, 50163, 50165, 50166, 50172, 50173, 50182, 50179, 50183, 50191, 50195, 50197, 50199, 50402, 50404, 50405, 50406, 50421, and 50422.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including Florida, South Carolina, Georgia, Alabama, Virginia, Ohio, Massachusetts, New York, Pennsylvania, Kentucky, Connecticut, Rhode Island, Indiana, Illinois, Nebraska, Minnesota, Arizona, California, Oregon, and Washington.
  • 제품 설명
    Double foot switch, type KF 2 1S/1 S-MED-AP, manufactured by the company Seute Schaltgerate. GmbH & Co. KG for Ziehm Imaging GmbH Germany, and used with Ziehm Imaging GmbH Mobile C-arm as a component thereof. Two versions were made: 2 pedal version KF 2 1S/1 S-MED-AP foot switch and 4 pedal foot switch version KF 2 1S/1 S-MED-AP This type of foot switch includes a pair of the dual foot switches assembled on a single metal bracket. The following labels may appear on the foot switch: || Labeled in part: "Fluoro- Store***ZIN Part no. # 58371***ZIR Part no. # 10-2985*** Left Pedal: Initiate Radiation***Right Pedal: Store Image***" || Labeled in part: "Fluoro - Cine***ZIN Part no. # 58415***ZIR Part no. # 10-2987*** Left Pedal: Initiate Radiation***Right Pedal: Switch into Cine mode***" || Labeled in part: "Fluoro - Mag***ZIN Part no. # 58413***ZIR Part no. # 10-2989*** Left Pedal: Initiate Radiation***Right Pedal: Switch through magnification***" || Labeled in part: "Fluoro -Snap***ZIN Part no. # 58417***ZIR Part no. # 10-2991*** Left Pedal: Initiate Radiation ***Right Pedal: Initiate Snapshot***" || Labeled in part: "DSA - CINE***ZIN Part no. # 58419***ZIR Part no. # 10-2993*** Left Pedal: Switch into DSA mode ***Right Pedal: Switch into Cine mode***" || Labeled in part: "Cine - Store***ZIN Part no. # 58421***ZIR Part no. # 10-2995*** Left Pedal: Switch into Cine mode***Right Pedal: Store Image***" || Labeled in part: "Cine - LONG:Endo ON/OFF & SHORT:Freeze*** ZIN Part no. # 58423***ZIR Part no. # 10-2997*** Left Pedal: Switch into Cine mode***Right Pedal: Long: Switch Endo On/Off Short: Freeze the endoscopic image on live screen***" || Labeled in part: "Cine- Endo ON /OFF***ZIN Part no. # 58425***ZIR Part no. # 10-2999*** Left Pedal: Switch into Cine mode***Right Pedal: Switch Endo On / Off***" || Labeled in part: "Fluoro - Swap***ZIN Part no. # 58427***ZIR Part no. # 10-3031*** Left Pedal: Initiate Radiation***Right Pedal: Swaps the image between the live and reference screens***" || Labeled in part: "DSA / MSA/RSA - OFF***ZIN Part no. #58429***ZIR Part no. #10-3033***Left Pedal: Switch DSA/MSA/RSA On***Right Pedal: Switch DSA/MSA/RSA Off***" || The KF 2 1S/1S-MED- AP foot switch is a component of the Mobile C-arm and is used by the physician to activate Fluoroscopic X-Ray for imaging by pressing the foot switch.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Ziehm Imaging Inc, 6280 Hazeltine National Dr, Suite 100, Orlando FL 32822-5114
  • 제조사 모회사 (2017)
  • Source
    USFDA