Events

Recall of Device Recall Caris Plus

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biosound Esaote, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    25428
  • Event Risk Class
    Class 2
  • Event Number
    Z-0299-03
  • Event Initiated Date
    2003-01-22
  • Event Date Posted
    2003-04-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25815
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
  • Reason
    Excessive power output due to a faulty voltage controller.
  • Action
    This is a professional use device, and service upgrade notices were issued to customers on or about 1/22/03 informing them that the firm will be contacted by a service representative to schedule a software upgrade.

Device

Device Recall Caris Plus
  • Model / Serial
    All Caris Plus units with PA220, PA121, PA122, PA023 or PA230 probes. All Megas units with PA122 or PA023 probes.
  • Distribution
    United States and Canada
  • Product Description
    Biosound Caris Plus Ultrasound System with phased array probes, model 7230. || Biosound Megas Ultrasound System with phased array probes, model 7250
  • Manufacturer
    Biosound Esaote, Inc.

Manufacturer

Biosound Esaote, Inc.
  • Manufacturer Address
    Biosound Esaote, Inc., 8000 Castleway Drive, Indianapolis IN 46250
  • Source
    USFDA