Events

Safety Alert for Mammo Graph Mammo and Mammo DR Mammography Unit, records 10216710296 and 10216710243, risk class III, serial number of affected equipment and municipalities located: PADPVG01001 - SANTA ROSA; PADPXU01001 - FRUTAL ;. PADPVG02001 - CERES ;. PADPW801001 - LAGES ;. PADPVG03001 - TERESINA ;. PADQKC01001 - GOIANIA ;. PADQKC02001 - IMPERATRIZ ;. PADRNO02001 - JARU ;. PADRWY02001 - ARAPIRACA ;. PADRNO01001 - AMARANTE ;. PADRWY01001 - CAPANEMA ;. PACZUO01001 - CACOAL ;. PAD63801001 - GOIANIA; PADED101001 - RIO VERDE ;. PADKZ801001 - MONTENEGRO.

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

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
    1714
  • Date
    2015-05-07
  • 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
    According to the record holder's information, if the gears are disengaged, the patient under examination procedure and with the compressed breast would be exposed to the risk of a potential adverse event due to the involuntary twisting of the 180 ° arm. The event has a high chance of occurrence. #### UPDATED ON 07/18/2017, the company sent a report of completion of the field action proving the accomplishment of correction, as planned.
  • Reason
    Possibility that the internal gears used for the rotating movement of the mammograph arm disaggregate due to inverted mounting of a mechanical component called "bearing spacer".
  • Action
    The company will correct the position of the "bearing spacer", which will allow adjustment of the entire assembly, located on the arm of the mammograph. Customers must schedule a technical visit to perform this action. Any questions get in touch with the company. Action code: FCOLAS 002-2015.

Device

Mammo Graph Mammo and Mammo DR Mammography Unit, records 10216710296 and 10216710243, risk class ...

Manufacturer

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