Events

Safety Alert for Commercial Names: CT Scanning System / Ingenuity CT; ANVISA registration numbers: 10216710191/10216710209; Risk class: III; Affected models: Brilliance 64, Ingenuity Core, Ingenuity Core128; Affected serial numbers: 10782, 10768, 10777, 10770, 10769, 95839, 95841, 95840, 95866, 95847, 95863, 95846, 95846, 320113.

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 (Cleveland), Inc. / 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
    1892
  • Date
    2016-05-06
  • 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 Healthcare is implementing the software version 3.5.5 upgrade to correct the problem described above. Solution Center will contact you to schedule the software update installation on your site. If you need more information or support for this issue, please contact our Solution Center at 0800-701-7789. Service from Monday to Saturday from 07 to 19h.
  • Reason
    Philips healthcare received field reports stating that certain brilliance 64, ingenuity core and ingenuity core128 systems running software version 3.5.4 exhibited intermittent swirl-like circular artifacts that may appear on rebuilt images and may diagnosis of affected images. the clinician should apply clinical judgment to determine if the images contained in the data set without artifacts contain enough information to make a diagnosis. if these images are sufficient, no action is required. if the images are not sufficient, a new patient scan may be required.
  • Action
    Action code FCO72800597. Software update

Device

Commercial Names: CT Scanning System / Ingenuity CT; ANVISA registration numbers: 10216710191/102...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc. / Philips Medical System...
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA