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.
This recall has been terminated (originally issued April 29, 2011).
- Recall Initiated
- May 15, 2009
- Posted
- April 29, 2011
- Terminated
- April 29, 2011
- Recall Number
- Z-2117-2011
- Quantity
- 15 units
- Firm Location
- Mountain View, CA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Serial numbers: 69243, 69250, 69299, 69310, 69315, 69318, 69320, 69331, 69339, 69342, 69345, 69352, 69358, 69360, and 69406.
Root Cause
Release of Material/Component prior to receiving test results
Action Taken
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.