Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. M
FDA device recall Z-0052-2014 · posted 2013-10-23 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Software issue results in inaccurate 3D image may result in ablation in wrong location.
- Action taken
- Siemens sent an Customer Safety Advisory Notification letter to all affected customers on July 10, 2013.The letter identified the product the problem and the action needed to be taken by the customer Letters provide steps to mitigate the risk and inform users that a software fix will be installed as soon as it is available. Siemens Service Engineers will contact all locations to arrange installation once fix is available. All personnel who use the ACUSON should be notified of the issue. Update September 17, 2013 : After discussion with CDRH, Siemens revised their letter to state that procedures using the ACUSON SC2000 system with BioSense Webster CARTO 3 equipped with CARTOSOUND Module and SoundSTAR Catheter should not be performed until the users system has been updated with the software upgrade that resolves the issue. For further questions please call (650) 694-5398.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 26 units
- Distribution
- Worldwide Distribution - US (nationwide) including the states of IL, PA, AZ, OR, OH, NY, CO, TX and CA., and the countries of France, Germany, Japan, Portugal, Saudi Arabia, Taiwan and Turkey.
- Date initiated
- 2013-07-10
- Date posted
- 2013-10-23
- Date terminated
- 2013-11-25
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUSON (K123622) | Siemens Medical Solutions USA, Inc. | 2012-12-05 |