Device Recall Siemens RAPIDPoint 500 system

  • Modèle / numéro de série
    Units shipped between the dates Oct 2011 - June 2015 and within the serial range of 30003-37040 not inclusive.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) Distribution and to the countries of : Albania, Algeria, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Bulgaria,Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany,Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Japan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands. New Zealand, Norway, P.R. China, Peru, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, U.A.E., United Kingdom and Vietnam.
  • Description du dispositif
    RAPIDPoint 500 Blood Gas Analyzer, || Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 10697306 || This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary || whole blood samples.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Siemens Healthcare Diagnostics Inc, 2 Edgewater Dr, Norwood MA 02062-4637
  • Société-mère du fabricant (2017)
  • Source
    USFDA