Safety Alert for Commercial name of the product: PCR Eleva /// Registration number: 10216719006 /// Models affected: S / S Plus / S Hi-res / Cosimax / Corado / Compact /// Serial number affected: 36626334./// Class risk of the product: I.

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 DMC GmbH / Philips Medical Systems (Lagoa Santa)..

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
    1983
  • Date
    2016-09-16
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • 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 plans to replace the system's power supply unit of the Compano Basic PCR scanner, which will eliminate this problem. A Philips Maintenance Engineer will contact you as soon as the Action Kit is available to be implemented. /// If you need to communicate with Philips about this program, please refer to Amendment Request 73200037./// If you need more information or support for this issue, please contact our Philips Solution Center through telephone 0800-701-7789. Service from Monday to Saturday from 07h to 19h.
  • Reason
    A faulty component of the compano reader's power supply may cause the power supply to burn and produce smoke in the compartment.
  • Action
    Field classification: Field correction by replacing the power supply unit of the PCR reader system Basic affected /// Field action code: FCO73200037 /// Recommendations to users and patients: The system can be used in accordance with the Instructions for Use without restrictions. In case of fire, the user may alert the fire department, use an extinguisher and / or evacuate the premises.