Events

Safety Alert for LINEAR DIGITAL ARTISTE ACCELERATOR, Registration 10234230172 - Serial Numbers: 5746; 5828

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Ltda.; Siemens AG; Siemens Medical Solutions USA, Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1691
  • Date
    2015-09-19
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    Simens Ltda informs that this field action aims to implement (software update) all necessary corrections previously already identified by other field actions (communications to clients). As previously reported in other releases to customers, the equipment could continue to be used until a new software version was released to correct / improve these issues.
  • Reason
    Siemens announces that the syngo rt therapisttm software version and the control console software have been updated to address the following safety issues: - automatic movement prevention in the event of a significant risk of collision; - repositioning of 160 mlc after the motion stop block; - restarting the command console; - support of fractional monitor units for virtual wedge; - loss of information after the change of the uid of the plan in the information system on cancer (ois); - calculation of incorrect automatic deviation in combination with images acquired with ctvision; - calculation of incorrect deviation in the adaptive targeting option; - interruption of the reconstruction of the cone beam; - table rotation values ​​for relative setup; - resumes during the wrong session in the case of 0 (zero) managed monitor units; - unintended movement of the table after the internal error message in the syngo rt therapist; - dose linearity quality control procedure for the imrt (physics primer user documentation update); - automatic sequence setup for bolus fields; - workflow information to change the patient for treatment from one digital linear accelerator to another. the corrective measures described in this field safety information affect the syngo rt therapisttm combination and the control console. both upgrades must be performed at the same time to ensure proper system operation.
  • Action
    The company guides the custody of the Portuguese Charter of this field action together with the Owner's Manual of the Linear Accelerator System for any queries.

Device

LINEAR DIGITAL ARTISTE ACCELERATOR, Registration 10234230172 - Serial Numbers: 5746; 5828

Manufacturer

Siemens Ltda.; Siemens AG; Siemens Medical Solutions USA, Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA