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U.S. Department of Health and Human Services

Class 2 Device Recall ACUSON X700 Ultrasound Systems

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  Class 2 Device Recall ACUSON X700 Ultrasound Systems see related information
Date Initiated by Firm April 02, 2014
Date Posted April 24, 2014
Recall Status1 Terminated 3 on November 12, 2015
Recall Number Z-1504-2014
Recall Event ID 68027
510(K)Number K123001  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
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.
Code Information Model numbers: 1065844  ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultrasound System (Korea) 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
685 E Middlefield Rd
Mountain View CA 94043-4045
For Additional Information Contact Sheila Pickering
650-694-5398
Manufacturer 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.
FDA Determined
Cause 2		 Software Design Change
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.
Quantity in Commerce 490
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.
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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