Device Recall VITEK 2 Compact computer system

  • 모델명 / 제조번호(시리얼번호)
    Manufactured from September, 2004, to present.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Algeria, Angola, Argentina, Australia, Austria, Azerbaidjian, Bahrain, Belarus, Belgium, Benin, Bolivia, Bosnia, Brazil, Bulgaria, Burkina Faso, Camaroun, Canada, Chad, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Democratic Republic of Congo, Demark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gabon, Georgia, Germany, Greece, Guatemala, Guinea, Herzegovina, Honduras, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mali, Mexico, Moldavia, Mongolia, Morocco, Myanmar, Netherlands, Netherlands, Nicaragua, Niger Niamey, Nigeria, Norway, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Yemen.
  • 제품 설명
    VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models: || (1) dc7100 8-port, Cat. #W0441; || (2) dc7100 8-port (refurbished), Cat. #W0441R; || (3) dc7700 8-port, Cat. #W0447; || (4) dc7700 8-port (refurbished), Cat. #W0447R; || (5) dc7800, Cat. #W0449; || (6) dc7800 (refurbished), Cat. #W0449R || (7) rp5700, Cat. #W0452; || (8) rp5700 (refurbished), Cat. #W0452R; || (9) rp5800 XPE, Cat. 413642; || (10) rp5800WES7, Cat. #413862; || (11) d530 6-port, Cat. #W0438; || (12) d530 6-port (refurbished), Cat. #W0438R; and || (13) d530 4-port, Cat. #W0437. || VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Biomerieux Inc, 595 Anglum Rd, Hazelwood MO 63042-2320
  • 제조사 모회사 (2017)
  • Source
    USFDA