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U.S. Department of Health and Human Services

Class 2 Device Recall ACUSON SC2000

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 Class 2 Recall
ACUSON SC2000
see related information
Date Posted April 10, 2013
Recall Status1 Terminated on February 14, 2014
Recall Number Z-1081-2013
Recall Event ID 64855
Premarket Notification
510(K) Number
K123622 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; 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 All units of this model.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc.
685 E Middlefield Rd
Mountain View, California 94043-4045
For Additional Information Contact Kristen Dorrough
650-969-9112
Manufacturer Reason
for Recall
When using the V5M transducer, the display of the temperature on the ACUSON SC2000 system can be lower than the actual temperature of the V5M transducer. This occurs only if the system hardware contains revision 4 of the MPI Board. There is a potential to cause esophageal burns in patients.
FDA Determined
Cause 2
DESIGN: Device Design
Action Siemens Medical Solutions USA Inc. sent a CUSTOMER SAFETY ADVISORY NOTIFICATION letter dated March 28, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A return response form is included for customers to complete and mail to the recalling establishment. Siemens stated additional follow up action will occur, once material is available, where Siemens field service engineers will visit each unit and replace the affected MPI 4 board. For further questions please call (650) 694-5747.
Quantity in Commerce 120 units
Distribution Worldwide Distribution - USA and countries of Australia, Austria, Bosnia Herzegovina, Belgium, Finland, France, Germany, India, Italy, Japan, Kuwait, Malaysia, Netherlands, Norway, P.R. China, Portugal, Rep.of Korea, Romania, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan and United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA INC.
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