Events

Rappel de Device Recall Artis zee

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
    80286
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2308-2018
  • 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=165053
  • 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
    After the large display returns from power save mode, it may not show an image, and stay black without showing an error message although x-ray is still possible. the problem does not occur during an ongoing procedure. if the problem occurs, the system cannot be operated normally. it may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
  • Action
    On May 1, 2018, the firm notified customers via Urgent Medical Device Correction letters. Users were warned that the Large Display may not show an image after it returns from power save mode. The Large Display stays black without showing an error message although X-Ray is still possible. The problem occurs sporadically, and does not occur during an ongoing procedure. The firm stated that there should be no influence on the previous treatment of patients. Users were instructed to follow standard emergency procedures in the event of system failures. It is recommended to consider reinforcing emergency procedures until the update has been completed. The firm's service organization will contact customers to arrange a date to correct the error by updating the firmware of the affected devices. Users were asked to promptly notify and instruct accordingly all staff within their organizations who need to be aware of the issue.

Device

Device Recall Artis zee
  • Modèle / numéro de série
    153992 154616 154551 154536 154096 154532 154157 154571 154074 154012 154612 153274 154090 154567 154480 154093 154502 154408 153987 154509 154079 154462 154098 154073 154076 153959 154653 154671 154556 153869 154633 154058 154155 154453 154579 154034 154560 154596 153708 153248 154048 153903 153819 154087 154606 154604 154581 154423 154546 154052 154501 154514 154562 154056 153999 154631 154089 154476 131020 154584 154610 153607 153886 154576 154602 154572 154564 153744
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution. US nationwide including Puerto Rico, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Luxembourg, Mexico, Myanmar, Netherlands, New Zealand, Norway, China, Paraguay, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
  • Description du dispositif
    Artis zee biplane, Material no. 10094141, for angiography and whole body radiographic/fluoroscopic procedures.
  • 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