8V3c transducer used with the ACUSON SC2000 ultrasound system. 8V3c transducer model number 10433823; ACUSON SC2000 mode
FDA device recall Z-1907-2011 · posted 2011-04-08 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 386 units
- Distribution
- Worldwide Distribution.
- Date initiated
- 2011-02-04
- Date posted
- 2011-04-08
- Date terminated
- 2011-10-04
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SC2000 DIAGNOSTIC ULTRASOUND SYSTEM (K102017) | Siemens Medical Solutions USA, Inc. | 2010-09-20 |