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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens ACUSON X300 Premium Edition Systems with software versions 5.0.00 and 5.0.01

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 Class 2 Recall
Siemens ACUSON X300 Premium Edition Systems with software versions 5.0.00 and 5.0.01
see related information
Date Posted April 25, 2011
Recall Status1 Terminated on April 25, 2011
Recall Number Z-2061-2011
Recall Event ID 53053
Premarket Notification
510(K) Number
K072676 
Product Classification System, Imaging, Pulsed Echo, Ultrasonic - Product Code IYO
Product Siemens ACUSON X300 Premium Edition Systems with software versions 5.0.00 and 5.0.01 (model numbers 10348531, 10348532 and 10348533), when using the V5Ms transducer (model number 08263703) and the Plus option (10427795) Product is an ultrasound imaging system intended for General Radiology,Fetal, Abdominal, Intaoperatve, Pediatric, Small parts, Neunatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and peripheral Vascular Applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. The Arterial Health Package software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published with peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the state of their cardiovascular system. The V5Ms is a multifrequency,multi-plane, phased sector array transducer, which can be introduced into the esophagus to obtain heart structure images. Transesophageal echocardiography is used to obtain unobstructed views of the heart surrounding tissue.
Code Information Premium Edition Systems with software versions 5.0.00 and 5.0.01 (model numbers 10348531, 10348532 and 10348533), when using the V5Ms transducer (model number 08263703) and the Plus option (10427795)
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
Product Failure-- When the 64-Channel System V5M is used in the 128-Channel mode, an over current fault occurs which shuts the system down.
FDA Determined
Cause 2
DESIGN: Software Design
Action Siemens sent a Customer Safety Advisory Notification letter on July 24, 2009. The letter identified the product, the problem, and the action to be taken by the customer. A software update will be conducted in the field. Until that update occurs, customers were instructed to image without the CW doppler to avoid a system shut down. Customers were instructed to contact their service support person with any questions. For questions regarding this recall call 650-694-5993.
Quantity in Commerce 70 units
Distribution Worldwide Distribution - USA including CA, CT, FL, MA, and TX and the countries of United Arab Emirates, Germany, Ecuador, Spain, France, Great Britian, Saudi Arabia, Sweden, Thailand, and South Africa.
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 = IYO and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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