Events

Recall of Device Recall 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
    28393
  • Event Risk Class
    Class 3
  • Event Number
    Z-0744-04
  • Event Initiated Date
    2004-02-02
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-08-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31753
  • 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 - mode does not appear on screen.
  • Action
    The recalling firm telephoned their direct accounts to inform them of the problem and the need to modify the software. The call were made from 2/2-16/04. The modification kits were sent to consignees via express delivery.

Device

Device Recall Acuson Cypress Echocardiography System
  • Model / Serial
    Catalog number 8264604; Serial numbers 73480 through 73535, 71165, 71561, 72532, 73125, and 73292.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to physicians and medical facilities in AZ, CA, CT, FL, IA, IL, NE, NV, NY, OH, TX, and WA. The product was also shipped to Australia, Brazil, Canada, Denmark, Germany, Italy, Japan, New Zealand, South Korea, and Sweden.
  • Product Description
    Acuson Cypress Echocardiography System
  • Manufacturer
    Siemans Medial Solutions USA, Inc

Manufacturer

Siemans Medial Solutions USA, Inc
  • Manufacturer Address
    Siemans Medial Solutions USA, Inc, 5168 Campus Dr, Plymouth Meeting PA 19462-1123
  • Source
    USFDA