Events

Recall of Device Recall ARTISTE , ONCOR and PRIMUS accelerators

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
    58534
  • Event Risk Class
    Class 2
  • Event Number
    Z-2216-2011
  • Event Initiated Date
    2011-03-31
  • Event Date Posted
    2011-05-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99531
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Reason
    Siemens has become aware of a potential safety issue that may result in mistreatment when customers are configured with the artiste linac rt therapist v4.2 in combination with rt oncologist v.4.2 and use the remote "online 2d image review.
  • Action
    The firm, Siemens, sent an "Urgent: Medical Device Correction Customer Safety Advisory Notice" on March 31, 2011 via Siemens Customer Service Group or certified mail to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to not use the "Online 2D Image Review" on the Syngo RT Oncologist 4.2; to always calculate the offset directly on the RTT 4.2 before it is applied for the treatment with the patient on the treatment table; include this notice in their syngo RT Therapist 4.2 System Owner Manual chapter "Safety Advisory Letter" where it should remain until the measures defined in the notice are performed, and in the interest of safety, perform the preventative measures noted in this notice and inform all affected personnel immediately. Siemens is currently working on a solution for the incremental loading workflow in syngo RT Therapist 4.2 and will provide a software update as soon as possible. Siemens will notify the customers as soon as an update for their system will be available. UPDATE: The release of Safety Update UI TH010/11/S to distribute the software update for RTTv4.2.94O04 began on April 15, 2011. If you have any questions, contact Regulatory Affairs at 925-602-8157.

Device

Device Recall ARTISTE , ONCOR and PRIMUS accelerators
  • Model / Serial
    Therapist Exoress Basis Part number 08515289 syngo Therapist Express Part Number 08162815 syngo RT Therapist Connect/ MOSAIQ OIS Part number 08168754.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: CA, FL, OH, PA and UT; and countries including: Australia, Belgium, Croatia, Germany, Japan, South Africa, Sweden and United Kingdom.
  • Product Description
    ARTISTE , ONCOR and PRIMUS accelerators that utilize the RT Therapist v4.2 system in combination with syngo RT Oncologist 4.2. || The ONCOR and PRIMUS may be updated to utilize the RT Therapist v4.2 software. The RT Oncologist v4.2 is currently only on Non-US systems. || Distributed by Siemens Healthcare, Concord, CA 94520 || Intended use: Radiation therapy
  • 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