Device Recall Carl Zeiss INTRABEAM PRS 500

  • 모델명 / 제조번호(시리얼번호)
    Intrabeam ser. #6402501246, Ion chamber ser. #SN001254; Intrabeam ser. #6402501241, Ion chamber ser. #SN001745; Intrabeam ser. #6402100932, Ion chamber ser. #SN001994; Intrabeam ser. #6402100958, Ion chamber ser. #SN002096; Intrabeam ser. #6402101042, Ion chamber ser. #SN002265; Intrabeam ser. #6402101029, Ion chamber ser. #SN002270; Intrabeam ser. #6402101034, Ion chamber ser. #SN002302; Intrabeam ser. #6402101105, Ion chamber ser. #SN002651; and Intrabeam ser. #6402101130, Ion chamber ser. #SN002684.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including AZ, CA, CT, DC, FL, GA, OH, and PA.
  • 제품 설명
    Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. || The INTRABEAM System is indicated for radiation therapy treatments
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Carl Zeiss Meditec AG, Rudolf-Eber-Str. 11, Oberkochen Germany
  • 제조사 모회사 (2017)
  • Source
    USFDA