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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 Device Recall ACUSON Sequoia System see related information
Date Initiated by Firm May 15, 2009
Date Posting Updated April 29, 2011
Recall Status1 Terminated 3 on April 29, 2011
Recall Number Z-2116-2011
Recall Event ID 53013
Product Classification System, imaging, pulsed doppler ultrasonic - Product Code IYN
Product ACUSON Sequoia 12.X C512/512 SS Base System, model number 10042700. 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: 69275,, 69301,, 69313,, 69335,, 69347,, 69353,, 69366,, 69391,, 69403, and, 69411.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P.O. Box 7393
Mountain View CA 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
Release of Material/Component prior to receiving 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 10 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 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.
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