Device Recall Philips XRay

  • 모델명 / 제조번호(시리얼번호)
    Product Codes: 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 722039, 722058, 722059 systems with release R8.2.16
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide in the states of : AK, AL, AZ, CA, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NJ, NY, OH, OR, PA, TN, TX, UT, WI, WV and the country of Canada.
  • 제품 설명
    Philips X-Ray Systems, Allura Xper with R8.2.16 || Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology (EP). The Allura Xper FD2O, Allura Xper FD2O/10 and Allura Xper FD2O/20 is intended for:  Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • 제조사 모회사 (2017)
  • Source
    USFDA