Events

Safety Alert for (Camara Range) / E.CAM Signature Series, record 10234230040, risk class III, lots / series: 550; 588; 1017; 3002; 3006; 3051; 4004; 4019; 4022; 5017; 5034; 5155; 7006; 7016; 7086; 7507; 8011; 8019; 8575; 8576; 8671; 9002; 9036; 10012. e.cam systems installed before December 31, 2004.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Ltda.; 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
    1651
  • Date
    2015-07-27
  • 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
    In addition to touch-key failure, enabling an e-stop or a system power failure between 0.05 and 0.1 seconds after the start of the movement, may cause this fault to occur. Even so, the record holder recommends reliably emergency stop.
  • Reason
    According to the record holder there is an account of unintentional movement of the sensor. the main cause of this movement was determined as a simultaneous failure of two components, the radial brake circuit and the touch keypad. this combination of failures resulted in shaft brake inefficiency, which gave rise to sensor movement.
  • Action
    The registration company directs customers to continue to use the equipment. It is recommended to observe the patient during the examination. The company has developed and will install an improved brake control circuit to correct this condition. You should ensure that this safety information is included in the instructions for use of the system. As usual, Siemens recommends observing the patient during the exams. If difficulties occur or a fault occurs while performing the daily touch-tone test, it is recommended to discontinue use and contact Siemens Technical Support. If unintended movement of the sensor is observed, remove the patient, interrupt the use of the system and contact Technical Assistance.

Device

(Camara Range) / E.CAM Signature Series, record 10234230040, risk class III, lots / series: 550; ...

Manufacturer

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