Events

Recall of Acuson Cypress Echocardiography System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemans Medial Solutions USA, 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
    26456
  • Event Risk Class
    Class 2
  • Event Number
    Z-0975-03
  • Event Initiated Date
    2003-04-01
  • Event Date Posted
    2003-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-01-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27715
  • 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
    System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
  • Reason
    Software problem - loss of data.
  • Action
    The recalling firm issued a letter dated 4/03 explaining the problem and the work around. A software upgarde is being provided free of charge to the customers.

Device

Acuson Cypress Echocardiography System
  • Model / Serial
    Catalog # 8264604. Serial numbers 70000 through 72000.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The device was shipped to hospitals and physicians nationwide. The device was also shipped to accounts in Argentina, Australia, Austria, Belgium, Boliva, Brazil, Canada, Chile, Columbia, Costa Rica, Cypress, Denmark, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, South Korea, Kuwait, Luxembourg, Malaysia, Mexico, netherlands, Norway, Philippines, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, and United Kingdom.
  • Product Description
    Acuson Cypress Echocardiography System. Imaging System
  • Manufacturer
    Siemans Medial Solutions USA, Inc

Manufacturer

Siemans Medial Solutions USA, Inc
  • Manufacturer Address
    Siemans Medial Solutions USA, Inc, 5168 Campus Drive, Plymouth Meeting PA 19462
  • Source
    USFDA