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.
This recall has been terminated (originally issued April 24, 2014).
- Recall Initiated
- April 2, 2014
- Posted
- April 24, 2014
- Terminated
- November 12, 2015
- Recall Number
- Z-1504-2014
- Quantity
- 490
- Firm Location
- Mountain View, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
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 / Code Info
Model numbers: 1065844 ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultrasound System (Korea)
Root Cause
Software Design Change
Action Taken
Siemens sent a Customer Safety Advisory Notification letter on April 2, 2014 to all affected customers via certified mail. The letter identified the affected product, problem and what actions to take until software is upgraded. For questions call 1-888-826-9702.