ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers
FDA device recall Z-2314-2015 · posted 2015-07-29 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual trace measurement tool in full screen format that has a low probability of misdiagnosis.
- Action taken
- Customer Safety Advisory notifications were sent by certified mail to US customers on June 25, 2015. Siemens Service organization coordinate the implementation of the field correction with the distributors for all countries. Letters advised users of the potential miscalculation on ACUSON S1000, ACUSON S2000, or ACUSON S3000 ultrasound systems with software version VC30A, VC30B, VC30C, or VC31A. The manual trace tool may incorrectly calculate the Time Average Velocity and subsequently incorrectly calculate the Pulsatility index. This could lead to potential misdiagnosis. To mitigate the problem users should not perform measurement utilizing the manual Doppler trace tool in a full screen display format. This issue will be resolved in a future software release. If you have any questions, please contact your Siemens Service for more information. Until the necessary repairs have been completed on your system, please share this information with all personnel within your organization who need to be aware of this issue. Siemens is continuing to ship in forward production and will be including the customer safety advisory notice with the shipment. Siemens will update the software for those customers as well once it is released. For further questions please call (650) 694-5398.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 1789 units
- Distribution
- Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Algeria, Angola, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia
- Date initiated
- 2015-06-25
- Date posted
- 2015-07-29
- Date terminated
- 2017-10-19
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUSON S1000 / S2000 / S3000 (K132804) | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2013-10-24 |