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U.S. Department of Health and Human Services

Class 2 Device Recall ACUSON X700 Ultrasound System

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  Class 2 Device Recall ACUSON X700 Ultrasound System see related information
Date Initiated by Firm September 05, 2015
Create Date April 27, 2016
Recall Status1 Terminated 3 on April 27, 2016
Recall Number Z-1572-2016
Recall Event ID 73886
510(K)Number K123001  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product ACUSON X700 Ultrasound System with software version 1.0.04.
Model numbers:
10658844  ACUSON X700 Ultrasound System
10658846 - ACUSON X700 Ultrasound System (Russia)
10658845 - ACUSON X700 Ultrasound System (Korea)

Radiology: The Siemens ACUSON X700 ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Renal, Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cepahalic, Adult Cephalic, Orthopedics, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Pelvic, Obstetrical, Gynecological and Urological applications.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Code Information Material (System) IVK Group Serial number: 10658844 ACUSON X700 356559 10658844 ACUSON X700 356733 10658844 ACUSON X700 356734 10658844 ACUSON X700 358714 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
685 E Middlefield Rd
Mountain View CA 94043-4045
For Additional Information Contact Scott Christiansen
650-994-5398
Manufacturer Reason
for Recall		 Due to a communication error between the software and V5Ms transducers rotation function, ACUSON X700 ultrasound systems at software versions 1.1.04, display an IMG_15 error message causes the system to lock up, which requires a reboot to recover system operation.
FDA Determined
Cause 2		 Software design
Action September 5, 2015 we initiated a correction via update program US020/15/S where we visited all four units and updated their software to version 1.0.05
Quantity in Commerce 4
Distribution Distributed in Germany, U.A.E., Hungary and Brazil.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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