Events

Safety Alert for Commercial Name: Allura Xper Angiography Equipment; ANVISA registration numbers: 10216710153/10216710206/10216710186/10216710299; Risk class: III; 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).

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
    1861
  • Date
    2016-04-05
  • 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
    Philips will contact you for scheduling and Philips maintenance engineers will install Software that solves the audible alarm problem. If you need any additional information or support regarding this issue, please contact our Solution Center at 0800-701-7789. Attendance from Mon to Sat from 07 a.m. to 7 p.m. /////////Recommendation to users and patients: The non-issue of the audible alarm occurs very intermittently. The user should always observe the real-time dose information and cumulative fluoroscopy time provided by the system. The fault condition is reset when the case of a new patient is started or when the system is reset.
  • 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. 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.
  • Action
    Action code FCO72200288. Recommendations to users and patients by means of a safety notice prepared in March / 2016 ///// Field Correction through Software Installation to solve the sound alarm problem.

Device

Commercial Name: Allura Xper Angiography Equipment; ANVISA registration numbers: 10216710153/1021...

Manufacturer

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