Events

Recall of ARTISTE syngo RT Therapist

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    53329
  • Event Risk Class
    Class 2
  • Event Number
    Z-0121-2010
  • Event Initiated Date
    2009-09-10
  • Event Date Posted
    2009-11-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85282
  • Notes / Alerts
    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.
  • Extra notes in the data
    Medical Linear Accelerator - Product Code IYE
  • Reason
    A failed data transfer is possible that may result in data not being recorded in the interfaced system. siemens medical solutions, inc. usa became aware of this potential issue with its artiste linear accelerator's syngo rt therapist v4.1 workspace (containing the siemens brand of verify and record application called primeview) and the lantis oncology information system product.
  • Action
    The firm issued a TH015/09/S Safety Modification syngo RT Therapist 4.1 Customer Advisory letter, dated September 10. 2009. the letter stated the reason for modification, the affected systems, working time, deadline, reimbursement, and reporting. The firm is preparing a software upgrade for the affected products to correct the problem. The letter was sent via certified mail.

Device

ARTISTE syngo RT Therapist
  • Model / Serial
    Product: syngo RT Therapist model/part #8162815 Product: syngo RT Therapist Assist model/part #8162807 Product: syngo RT Therapist Express Basic model/part #8151289 Product: syngo RT Therapist Express Assist model/part #8151289
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Spain, Germany, Poland, Australia, Malaysia, New Zealand, the UK, India, Ireland, Egypt, Italy, Belgium, Republic of Korea, and Canada.
  • Product Description
    Siemens ARTISTE syngo RT Therapist, Therapist Assist, Therapist Express Basic, and Therapist Express Assist Systems, manufactured by Siemens Medical Solutions, Concord, CA
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source
    USFDA