Events

Safety Alert for Product name: Vital Signs Monitor ANVISA Registration Number: 80145901192 Hazard Class: III Affected Model: CARTO 3 System Affected Series Numbers: SKU: FG540000 | SNs: 13173; 13213; 11567; 14218; 13208; 50203; 50531; 14718; 14528; 50573

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Biosense Webster (Israel) Ltd..

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
    2104
  • Date
    2016-10-18
  • 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
    1. Carefully read the Medical Device Correction notice. 2. If there is a CARTO® 3 System currently in the hospital, the system has already been corrected and you should check if you received a Field Service Report, stating that the "system is in order". 3. Analyze, complete, sign and return the Confirmation Form, according to the instructions on the form. 4. In the future, if a CARTO® 3 System is installed in your hospital, you should perform a clinical procedure only after you have received a Field Service Report with a date after the device is installed, indicating that the "system is in order". 5. Stay aware of this notification and pass it on to everyone at your facility who needs to be informed.
  • Reason
    Biosense webster, inc. recently became aware that some systems were transported and installed incorrectly in hospitals in brazil by clinical experts from biosense webster. according to the carto® system instructions for use (ifu) 3, only members of the biosense webster technical services team are authorized to install these systems correctly. all impacted carto® 3 systems must be fully tested and approved by the biosense webster technical services team.
  • Action
    Field Action Code 16000135 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will make a correction in the field.

Device

Product name: Vital Signs Monitor ANVISA Registration Number: 80145901192 Hazard Class: III Affec...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Biosense Webster (Israel) Ltd.