—#89055

Product

Acuson Antares Ultrasound System Diagnostic Ultrasound system

FDA product code: ITX — Transducer, Ultrasonic, Diagnostic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K052021
Affected lot / code info: Model Numbers begins with 1003, 1004, 059 and 086 with product version 5.0, and softeare version 200.0.079

Why it was recalled

Software safety guard measures on the device malfunctioned to prevent the temperature from going over its limits when the device is used.

Root cause (FDA determination)

Software design

Action the firm took

Field notification in the form of a Customer Safety Advisory Notice was initiated on 09/30/2009 by the firm, and the notice was mailed to all affected customers Siemens sent a CUSTOMER SAFETY ADVISORY NOTIFICATION letter on September 30, 2009. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to disconnect and reconnect the V5Ms transducer between uses until their local Customer Service Engineer installs the software update to their system. For any questions customers were to contact their local service support person. For questions regarding this recall call 650-694-5398.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 1230 Shorebird Way P.O. Box 7393, Mountain View, California 94043

Distribution

Distribution pattern: Worldwide Distribution - United States (nationwide) and the countries of Australia, Austria, Azerbaijan, Brazil, Belarus, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Guatemala, Croatia, India, Indonesia, Italy, Jordan, Japan, Latvia, Malaysia, Mexico, Moldova, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.

Timeline

Recall initiated: 2009-09-30
Posted by FDA: 2011-01-12
Terminated: 2012-06-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #89055. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.