Events

Safety Alert for CLINITEK Status +, Brand: Siemens, Registration: 10345161788, risk class: I. ////. CLINITEK Status, Mark: Siemens, Registration: 10345160454, hazard class: I .. Serial numbers: SEE ANNEX

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics 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
    1511
  • Date
    2014-10-21
  • 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 record-holder, a problem with the equipment's power adapter may result in increased potential for electric shock to the user.
  • Reason
    Siemens healthcare diagnostics reported damage to the external power adapters that come with clinitek status®, clinitek status® +, and clinitek connect status® connected to the urine analyzers.
  • Action
    Siemens advises its customers to turn off the device and disconnect the power adapter from the power outlet to check the Code Identification Register raised. • If your power adapter has one of the aforementioned raised ID codes, immediately stop use and discard the power adapter. • If your power adapter does not have one of the ID codes listed above but is cracked or damaged in some way, immediately stop use and discard the adapter.

Device

CLINITEK Status +, Brand: Siemens, Registration: 10345161788, risk class: I. ////. CLINITEK Statu...

Manufacturer

Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA