FDAFDA · Food and drugs·Recall number Z-1504-2014
Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02. ultrasound imaging system.
Published April 30, 2014 · Recall initiated: April 2, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
When fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are used during an Obstetric or Gynecology study, data from the previous patient could replace the current patient's date in the report.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Distributor
- Worldwide Distribution - US Nationwide and the countries of Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg., Brunei, Chile, Colombia, Croatia, Ecuador, Egypt, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Kuwait, Latvia, Libya, Liechtenstein, Malaysia, Mauritius, Montenegro, Namibia, Nepal, Nigeria, Norway, Palestinian Ter, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Saudi Arabia, Slovakia, South Africa, Spain, Switzerland, Taiwan, Turkey, Turkmenistan, U.A.E., United Kingdom.
- Lot
- Model numbers: 1065844 ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultrasound System (Korea)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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