Events

Recall of Sonoline G50/G60 Ultrasound System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical 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
    49377
  • Event Risk Class
    Class 2
  • Event Number
    Z-2468-2008
  • Event Initiated Date
    2008-08-05
  • Event Date Posted
    2008-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73228
  • 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
    Ultrasound System - Product Code IYN
  • Reason
    As a result of bugs and calculation errors, the system may display incorrect or fail to display mechanical index and thermal index values.
  • Action
    The firm initiated its field correction on 08/05/2008. The firm's service personnel will make site visits to correct the problem and install the revised software (version 1.5.0c). Contact Siemens Medical Solutions USA, Inc. at 1-650-694-5993 for assistance.

Device

Sonoline G50/G60 Ultrasound System
  • Model / Serial
    Model numbers 07482800, 07482818, 07482826, 07478139, 07478147, and 07482479
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide
  • Product Description
    Sonoline G50/G60 Ultrasound System, Software versions 1.0.0 to 1.5.0b. The product is a general purpose, mobile software controlled diagnostic ultrasound system.
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc., 1230 Shorebire Way, P.O. Box 7393, Mountain View CA 94043
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA