Events

Safety Alert for DigitalDiagnost Radiology System - Registration No. 10216710214, Serial Numbers: 13000321, 426121 / SN09000086, 426122 / SN09000092, 456396 / SN10000277, 483715 / SN11000504, 512026 / SN12000272, 514483 / SN13000004, 521862 / SN13000033

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Philips Medical Systems Ltda.; Philips Medical Systems DMC GmbH.

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
    1502
  • Date
    2014-11-05
  • 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
    The company makes it clear that if the hook does not securely support the feet in an upright position, the support may fall and injure the operator or patient. #### UPDATED 7/18/2017, the company submitted field action proving the replacement of the part as planned.
  • Reason
    The platform for the entire column exams can be fixed in the upper position. when the clamp (hook) is not adjusted in its correct position, the foot support is not secured securely. if it falls, it may hurt the operator's or patient's foot (for example, when moving the stand or when the operator can not fix it correctly when moving the stand up). the following factors are necessary for this situation to occur: - hook not properly adjusted - operator does not recognize that the hook is not engaged in the correct place - patient support is moved (rotated) - hook is not secure - foot is in "risk area".
  • Action
    The customer / user should always check the correct hook position and whether the hook is locked. (Press the hook down until it locks in place) Ensure that the hook is in the position shown in the figure with the green arrow (at the safety warning).

Device

DigitalDiagnost Radiology System - Registration No. 10216710214, Serial Numbers: 13000321, 426121...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems DMC GmbH
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA