Recall Z-1504-2014— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-1504-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-02

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2014-04-02, terminated 2015-11-12. It names one FDA 510(k) clearance: K123001. Product: 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.. Reason: 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..

Recalling firm: Siemens Medical Solutions USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-04-02
Terminated: 2015-11-12
Firm location: Mountain View, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K123001 — ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc.·cleared 2012-10-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.