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Class 2 Device Recall ACUSON Sequoia System |
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Date Initiated by Firm |
May 15, 2009 |
Date Posted |
April 29, 2011 |
Recall Status1 |
Terminated 3 on April 29, 2011 |
Recall Number |
Z-2117-2011 |
Recall Event ID |
53013 |
Product Classification |
System, imaging, pulsed doppler ultrasonic - Product Code IYN
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Product |
ACUSON Sequoia 12.X GI Base System, model number 10042701. 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: 69243, 69250, 69299, 69310, 69315, 69318, 69320, 69331, 69339, 69342, 69345, 69352, 69358, 69360, and 69406. |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc. 1230 Shorebird Way P.O. Box 7393 Mountain View CA 94043
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For Additional Information Contact |
Kristen Dorrough 650-694-5993
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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.
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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 |
15 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
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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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