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U.S. Department of Health and Human Services

Class 2 Device Recall ACUSON SC2000 Ultrasound System

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 Class 2 Device Recall ACUSON SC2000 Ultrasound Systemsee related information
Date Initiated by FirmAugust 19, 2015
Date PostedSeptember 17, 2015
Recall Status1 Terminated 3 on October 19, 2017
Recall NumberZ-2783-2015
Recall Event ID 72094
510(K)NumberK123622 
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
ProductACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Code Information Model 10433816: Serial numbers: 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Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc.
685 E Middlefield Rd
Mountain View CA 94043-4045
For Additional Information ContactSheila Pickering
650-694-5398
Manufacturer Reason
for Recall
The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient name as unique patient instances when registered on the same ultrasound system. If these differences are not corrected at the time of registration, the system does not capture images or clips.
FDA Determined
Cause 2
Software design
ActionSiemens sent a Customer Safety Advisory Notification letter on August 19, 2015 by certified mail. The letter identified the affected product, problem and actions to be taken. The letter states that this issue will be resolved in a future software release. If you have any questions,please contact your customer care center for information regarding timelines and status. Until the necessary repairs have been completed on your system, please share this information with all personnel within your organization who need to be aware of this issue. The Siemens Service organization coordinates the implementation of the field correction with the distributors for all countries.
Quantity in Commerce2039 devices
DistributionWorldwide distribution. US Nationwide and the countries of Albania, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia Herzeg., Brazil, Brunei, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, El Salvador, Finland, France, Georgia, Germany, Hungary,, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Lithuania, Malaysia, Maldives, Malta, Mauritius, Mexico, Netherlands, New Zealand, Nigeria, Norway, Oman, P.R. China, Pakistan, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Uzbekistan, Venezuela, and Vietnam.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IYN
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