Device Recall Gendex eXpert DC Intraoral Dental XRay System

  • 모델명 / 제조번호(시리얼번호)
    Model # EXPERTDC75NA, serial numbers 2007017, 2006983, 2007018, 2006982, 2003916, 2007015, 2007051, 2007021, 2006975, 2003900, 2006987, 2007027, 2006989, 2003812, 2007024, 2006985, 2006986, 2006980, 2007025, 2007026, 2006979, 2006976, 2003840, 2003906, 2003820, 2006977, 2007023, 2006978, 2003917, 2003907, 2003904, 2007028, 2007022, 2007019, 2003829, 2003876, 2003909, 2003920, 2003862, 2007029, 2007016, 2003937, 2003877, 2007020, 2003835, 2003908; model # EXPERTDC55NA, serial numbers 2004394, 2004396, 2004437, 2004430, 2004436, 2004416
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA including the states of Iowa and Illinois.
  • 제품 설명
    Gendex eXpert DC Intraoral Dental X-Ray System || Device is to be used as an extra-oral source of X-Rays in Dental Radiography
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Gendex Dental Systems, 1910 N Penn Rd, Hatfield PA 19440-1959
  • Source
    USFDA