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

• Date Initiated by Firm: July 24, 2009
• Date Posted: April 25, 2011
• Recall Status: Terminated on April 25, 2011
• Recall Number: Z-2061-2011
• Recall Event ID: 53053
• 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 CA 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: 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 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.

• 510(K) Database: 510(K)s with Product Code = IYO