Events

Safety Alert for Product Category: Angiography Equipment Allura Xper. Technical Name: Angiography Equipment. ANVISA registration number: 10216710153. Class of risk: III - High Risk. Models Affected: ALLURA XPER FD10 OR table; ALLURA XPER FD20 OR table; ALLURA XPER FD10 (ground); ALLURA XPER FD10 (ceiling); ALLURA XPER FD20 (ground); ALLURA XPER FD20 (ceiling). Series Affected: See below

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
    2020
  • Date
    2016-09-23
  • 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
    This non-compliance with 21CFR1020.32 (h) (2) (ii) and IEC 60601-2-54, clause 203.6.2.1.c., does not directly cause a hazardous situation. However, the beep is one of the tools available to help prevent unnecessary radiation to the patient. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Reason
    Philips healthcare has identified, through customer complaints and internal testing, an intermittent electronic defect in the product. under certain circumstances, a software error may lead to a situation where the five-minute fluoroscopy beep is not emitted as required in 21cfr1020.32 (h) (2) (ii) and iec 60601-2-54 , clause 203.6.2.1.C. no injuries attributed to the problem were reported.
  • Action
    Field Action Code FCO72200342 triggered under the responsibility of the company Philips Medical Systems Ltda. Field Correction: Software update.

Device

Product Category: Angiography Equipment Allura Xper. Technical Name: Angiography Equipment. ANVIS...

Manufacturer

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