Events

Recall of Device Recall Voluson Pro/Expert

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by General Electric Med. Sys. Ultrasound.

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
    35066
  • Event Risk Class
    Class 3
  • Event Number
    Z-1172-06
  • Event Initiated Date
    2006-02-24
  • Event Date Posted
    2006-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45212
  • 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
    In the cardiac measurement section of the device the calculation of the 'pg mean' (mean pressure gradient) leads to an erroneous result. it is recommended that customers with affected units do not use the measurement in question 'pg mean' for any diagnostic or therapeutic decision, and 'pg mean' values should not be included in any patient documentation.
  • Action
    An Urgent Medical Device Correction letter to customers 04/17/2006, states the product affected, provides a recommendation for affected units continued use until a software update is provided to the facility by a GE Healthcare Representative. Customers are recommended to not use the measurement in question 'PG Mean' for any diagnostic or therapeutic decision, and 'PG mean' values should not be included in any patient documentation.

Device

Device Recall Voluson Pro/Expert
  • Model / Serial
    Software versions 4.0.0, 4.0.1, 4.0.2, 4.0.3, 4.0.4, 4.0.5, 5.00, 5.0.1. Serial number ranges A06251 thru A09914, A12012 thru A31198 and A35001 thru 35097 may include devices that are not subject to the correction.  Serial number ranges A10000 thru A11087 and A31201 thru A33742 only include devices subject to the correction
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Puerto Rico and OUS to include: Algeria, Argentina, Austria, Belgium, Bosnia and Herzegovina, Brazil, Republic of Bulgaria, Byelorussian SSR, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, DVU Australia, Ecuador, Egypt, Finland, France, Federal Republic of Germany, Greece, Hong Kong, Republic of Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Kuwait, Republic of Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Kingdom of Saudi Arabia, Singapore, Republic of Slovenia, Spain, Sudan, Sweden, Switzerland, Taiwan, United Republic of Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Venezuela, Vietnam, Yemen, Yugoslavia
  • Product Description
    Voluson 730 Expert, Voluson 730 Pro, Voluson 730 ProV with software versions 4.0.0, 4.0.1, 4.0.2, 4.0.3, 4.0.4, 4.0.5, 5.00, 5.0.1. The device is a general-purpose diagnostic ultrasound system.
  • Manufacturer
    General Electric Med. Sys. Ultrasound

Manufacturer

General Electric Med. Sys. Ultrasound
  • Manufacturer Address
    General Electric Med. Sys. Ultrasound, 4855 W Electric Ave, West Milwaukee WI 53219-1628
  • Source
    USFDA