Device Recall Carl Zeiss INTRABEAM PRS 500

  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AZ, CA, CT, DC, FL, GA, OH, and PA.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Carl Zeiss Meditec AG, Rudolf-Eber-Str. 11, Oberkochen Germany
  • Manufacturer Parent Company (2017)
  • Source
    USFDA