Events

Safety Alert for Mobile Model X-ray Systems BV 300. Parts Nos .: 9896 000 06801, 9806 000 06802; In Series: DBXXX, DDXXX, DEXXX (where X in any position corresponds to numbers 0 to 9), DG0001 to DG0129, DH0001 to DH0033, DJ0001 to DJ0152, DK0001 to DK0076

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

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
    691
  • Date
    2003-03-07
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The c-tilt support, in the aforementioned x-ray systems, can bend or break, allowing the c-arm to fall out of the support and reach a patient. the manufacturer notified by letter dated 27 september 2002.
  • Action
    Make sure you received the letter from Philips on 27 September 2002. Identify and isolate any affected product in your inventory. Contact your local Philips representative for additional information, to schedule a technical visit in your area, and to arrange the units in your inventory. ANVISA has provided the Occurrence Notification Forms on the Internet http://www.anvisa.gov.br/sistec/notificacaoavulsa/notificacaoavulsa1.asp so that you notify if there are any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Mobile Model X-ray Systems BV 300. Parts Nos .: 9896 000 06801, 9806 000 06802; In Series: DBXXX,...

Manufacturer

Philips Medical Systems North America
  • Source
    ANVSANVISA