Events

Safety Alert for Transducers for Ultrasound

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Siemens Medical Solutions Usa, Inc..

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
    I1404-148
  • Event Number
    2008DM-0001867
  • Date
    2014-04-15
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=205
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer reports that the use of the transducer with a user-defined configuration that includes the 100% setting for the power output may cause the temperature of the transducer surface to exceed the maximum permissible limit, potentially increasing the risk of patient burn, leading to there are adverse events on the patient.

Device

Transducers for Ultrasound
  • Model / Serial
    PA230 - 10852384
  • Product Description
    Ultrasound system for applications of: abdomen, intraoperative, obstetrics and gynecology, pelvis, breast, orthopedics, urology, small parts, transcranial, musculoskeletal, vascular, peripheral vascular, cardiology, intracardiac and transesophagy for neonatal, pediatric and adult patients.
  • Manufacturer
    Siemens Medical Solutions Usa, Inc.

Manufacturer

Siemens Medical Solutions Usa, Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA