ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultras
FDA device recall Z-2783-2015 · posted 2015-09-17 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient name as unique patient instances when registered on the same ultrasound system. If these differences are not corrected at the time of registration, the system does not capture images or clips.
- Action taken
- Siemens sent a Customer Safety Advisory Notification letter on August 19, 2015 by certified mail. The letter identified the affected product, problem and actions to be taken. The letter states that this issue will be resolved in a future software release. If you have any questions,please contact your customer care center for information regarding timelines and status. 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. The Siemens Service organization coordinates the implementation of the field correction with the distributors for all countries.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 2039 devices
- Distribution
- Worldwide distribution. US Nationwide and the countries of Albania, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia Herzeg., Brazil,
- Date initiated
- 2015-08-19
- Date posted
- 2015-09-17
- Date terminated
- 2017-10-19
- Location
- Mountain View, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUSON (K123622) | Siemens Medical Solutions USA, Inc. | 2012-12-05 |