Events

Rappel de Device Recall ARTIS Pheno Interventional Fluoroscopic XRay System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Siemens Medical Solutions USA, Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    80272
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2283-2018
  • Date de mise en oeuvre de l'événement
    2018-05-01
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=165013
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Cause
    If the c-arm is manually moved in the longitudinal direction to a fully extended position, the system's safety stop mechanism may be activated. as a result, the c-arm stops the movement and can drop up to 20 mm (0.8 ). under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the c-arm drop. this could lead to a situation in which it is necessary to stop the clinical treatment or continue the treatment on an alternative system.
  • Action
    On May 1, 2018, the firm distributed Urgent Medical Device Correction letters to its affected customers. The letter instructed customers to follow standard emergency procedures they have in place in the event of system failures. The firm recommended considering reinforcing the emergency procedures until the update has been completed. As an immediate measure, operators were instructed to avoid driving the C-arm into a fully extended longitudinal position. The firm is currently developing a solution to eliminate the root cause of the problem. The solution will be distributed to all affected customers upon completion. Customers were asked to forward the safety information to any other organizations that could be affected.

Device

Device Recall ARTIS Pheno Interventional Fluoroscopic XRay System
  • Modèle / numéro de série
    164033 164071 164034 164095 164057 164055 164054 164080 164072 164088 164048 164094 164068 164019 164013 164073 164027 164026 164025 164060 164083 164021 164066 164075 164084 164086 164074 164098 164028 164053 164063 164064 164024 164049 164022 164018 164100 164097 164011
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Healthcare facilities in AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, NE, NJ, NY, OH, TN, TX, UT, and VA. Foreign distribution to Australia, Austria, Belgium, Denmark, France, Germany, Italy, Japan, Kuwait, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
  • Description du dispositif
    ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA