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U.S. Department of Health and Human Services

Class 2 Device Recall ACUSON Sequoia System

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 Class 2 Recall
ACUSON Sequoia System
see related information
Date Posted April 29, 2011
Recall Status1 Terminated on April 29, 2011
Recall Number Z-2115-2011
Recall Event ID 53013
Premarket Notification
510(K) Number
K063085 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product ACUSON Sequoia C512/512SS Adv PE 10.0 System, model number 10041127. Distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA. The ACUSON Sequoia is a general purpose Diagnostic Ultrasound system. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in: B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, Harmonic Imaging or 3D imaging on a FPD Display. The ACUSON Sequoia is intended for the following applications: Abdominal, General Imaging and Cardiolgoy for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breat, testes, thyroid and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Transesophageal, Transrectal, Transvaginal, Peripheral Vessels and Musculo-sceletal (superficial and conventional) applications. The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes.
Code Information Serial numbers: 66214, 69268, 69302, and 69356.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P.O. Box 7393
Mountain View, California 94043
For Additional Information Contact Kristen Dorrough
650-694-5993
Manufacturer Reason
for Recall
Shock Hazard. The manufacturer failed to set the system power switch to "ON" during the line level leakage and high pot current draw testing.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results
Action Siemens Medical Solutions USA, Inc. sent a Customer Safety Advisory Notification letter out on May 15, 2009. Service engineers were to visit each customer to conduct necessary testing. For questions regarding this recall call 650-694-5993.
Quantity in Commerce 4 units
Distribution Worldwide Distribution - USA including CA, IL, MD, NC, OH, and UT and the countries of Australia, China, Denmark, Spain, South Korea, Norway, Poland, Russia and Sweden.
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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