Terminated

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.

FDA Recall Z-1504-2014 · Posted 2014-04-24

Recalling FirmSiemens Medical Solutions USA, Inc.

Recall StatusTerminated

Product CodeIYN

Date Initiated2014-04-02

Date Terminated2015-11-12

Product Quantity490

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.

Firm Action

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.

Root Cause

Software Design Change

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123001ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc. · 2012-10-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.