Events

Safety Alert for E.CAM SIGNATURE SERIES MARK SIEMENS - Camera Camcorder - Model E.CAM Signature Series, brand SIEMENS - Registration 10234230040 ### SPECT SYSTEM (Nuclear Image Formation System) - Symbia Model E; Symbia S - Record 10345161991 - VIEW PRODUCT DESCRIPTION

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos S.A; 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
    1849
  • Date
    2016-03-30
  • 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
    According to the company: "Recommendation to users and patients: We recommend the users of the target devices of this field action to inform all responsible staff about these reinforcements of instructions that were made in the user manual. Continued use of the system is not impaired, meaning users can continue to use the systems. Also, we ask that users make sure that this safety information has been attached to the instructions for using the system. Finally, we always warn that all information regarding the use of systems should be available to all operators of the equipment. "
  • Reason
    Siemens healthcare informs that it has received complaints regarding incidents, which during the exchange of collimator activities have resulted in injury to the operator. it has been determined that while the existing user's manual is correct, additional add-ins with visual aids may promote clarity and appropriately emphasize the collimator process exchange.
  • Action
    The action of field code MI005 / 16 / S initiated by Siemens deals with a Letter to the Client, SEE LETTER TO CUSTOMERS AND DISTRIBUTION MAP.

Device

E.CAM SIGNATURE SERIES MARK SIEMENS - Camera Camcorder - Model E.CAM Signature Series, brand SIEM...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Medical Solutions USA, Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA