8V3c transducer used with the ACUSON SC2000 ultrasound system. 8V3c transducer model number 10433823; ACUSON SC2000 model number 10433816. Siemens Medical Solutions USA, Inc. Business Unit Ultrasound 1230 Shorebird Way, Mountain View, CA 94043 High-density array transducer for pediatric and fetal echocardiography applications.
FDA Recall Z-1907-2011 · Posted 2011-04-08
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Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2011-02-04
Date Terminated2011-10-04
Product Quantity386 units
Reason for Recall
When using the 8V3c transducer in color mode, the derated Ispta 3 (Spatial Peak-Temporal Average Intensity) may exceed the limit stated in the instructions for use.
Firm Action
A Customer Safety Advisory Notification was initiated on 2/4/2011 and sent via certified mail. The letter identified the affected product and described when the problem occurs along with the associated potential risk. The firm recommends that users not use the 8V3c until the software issue is fixed. The firm is working to release a software update and customers' local Customer Service Engineer will install new software on their system when it is available. Customers should direct their questions to their local service support person. The information in the letter should be shared with all personnel within the organization who need to be aware.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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