Acuson Antares Ultrasound System Diagnostic Ultrasound system
FDA device recall Z-0896-2011 · posted 2011-01-12 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Software safety guard measures on the device malfunctioned to prevent the temperature from going over its limits when the device is used.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- ITX
- Quantity affected
- 452
- Distribution
- Worldwide Distribution - United States (nationwide) and the countries of Australia, Austria, Azerbaijan, Brazil, Belarus, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece,
- Date initiated
- 2009-09-30
- Date posted
- 2011-01-12
- Date terminated
- 2012-06-18
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER (K052021) | Siemens Medical Solutions USA, Inc. | 2005-08-17 |