Events

Safety Alert for Magnetic Resonance Imaging Equipment, INGENIA / INTERA / ACHIEVA; records: 10216710217; 10216710194; 10216710205; Brand Philips; Risk class II; serial number: 17176.

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 Nederland B.V.

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
    1591
  • Date
    2015-05-15
  • 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 registry holder, there is a risk of incorrect diagnosis. There is only one affected equipment in Brazil.
  • Reason
    According to the record keeper, cross-reference cross-line lines are displayed in an incorrect position in the fused image, which was generated through post-processing mobiview.
  • Action
    The company will upgrade the software by reviewing cross-sweep planning only on unmelted stations.

Device

Magnetic Resonance Imaging Equipment, INGENIA / INTERA / ACHIEVA; records: 10216710217; 102167101...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA