Events

Safety Alert for Ultrasonic diagnostic equipment EPIQ, Model EPIQ 7, hazard class III, serial numbers: US115B0096 / US914B0277.

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
    1585
  • Date
    2015-05-13
  • 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 company, if a health care provider makes a clinical decision based on a Cardiac Index calculated using an incorrect BSA without considering other indicators of cardiac function, the result may be an incorrect diagnosis and / or delayed or incorrect therapy. ///// ** this action will be implemented in conjunction with 2 other FCOs reported: FCO79500336- Epiq 5 (Pediatric Conversion Correction) FCO79500337- Epiq 7 (Pediatric Conversion Correction).
  • Reason
    According to the record holder there is an error in the conversion of the unit weight and height, in the metric setting, in the calculation for the patient's body surface area that results in incorrect calculation.
  • Action
    The registry holder will perform a field correction of the equipment and advises users to verify that the version of the software used is affected. Philips corrected this problem in versions 1.3.3 and higher. If you have a software version affected, contact your local Philips representative to schedule an upgrade of your software. Note: If Pediatric Cardiology is enabled, please contact your local Philips representative urgently to schedule an update of your software in accordance with FCO79500337. Until your software can be upgraded, the situation can be avoided by ensuring that the Patient Data Units setting is set to "English" units. If this setting is not acceptable to your institution and you need to use the "Metric" units, you can avoid the problem by ensuring the following: 1. After turning on the system, open the Patient Data screen before including an examination. This will put the Patient Data screen back in an appropriate status and the problem will not occur. 2. Ensure that the Patient Data screen is maintained in the Metric units instead of English units. If a height or weight value has to be reported in English [English] units, then it must be converted to Metric manually to avoid the problem. Finally, ensuring that the Patient Data screen is using the Metric units before loading the data of any examination will prevent the data from this examination from being changed.

Device

Ultrasonic diagnostic equipment EPIQ, Model EPIQ 7, hazard class III, serial numbers: US115B0096 ...

Manufacturer

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