Events

Rappel de Device Recall Syngo.plaza Picture Archiving and Communication 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
    79054
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0495-2018
  • Date de mise en oeuvre de l'événement
    2017-08-18
  • 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=161248
  • 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
    System, image processing, radiological - Product Code LLZ
  • Cause
    Software update to correct several issues that include (1)potential data loss, (2) study mix-up, (3) incorrect measurements on multi-frame images, (4) dearchiving issue, and (5) unauthorized access of data due to inadequate permissions for shared folders.
  • Action
    Siemens released a software update VB20A_HF04 and a Customer Information Letter was sent with Update Instruction SY010/17/P. Service reports for the affected sites will be monitored to ensure the recall was effective. For further questions, please call (610) 219-6461.

Device

Device Recall Syngo.plaza Picture Archiving and Communication System
  • Modèle / numéro de série
    Syngo.plaza with software version VB20A; Model numbers: 10863171, 10863172, 10863173
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA (nationwide) Distribution to the states of : AL, CT, FL, KS, LA, MA, MI, MN, MO, MS, NE, NY, OH, OR, PA, TX and WI. Foreign consignees were not reported as device is manufactured outside the U.S.
  • Description du dispositif
    Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173 || Syngo.plaza is a Picture Archiving and Communication System (PACS) software device intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.
  • 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