ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imagi
FDA device recall Z-1584-2015 · posted 2015-05-06 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- In certain situations, loss of post exercise images can occur in Stress Echo.
- Action taken
- On 07/11/2012 a field corrective action was initiated via update programs US016/12/P to update all affected SC2000 customers to software version VA20C, which contains the fix to the described issue. Each customer received a site visit to install the software update.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 476
- Distribution
- Worldwide Distribution -- US and Albania, Australia, Austria, Bangladesh, Bulgaria, Canada, Colombia, Denmark, Ecuador, Egypt, France, Germany, Hungary, Iceland, India, Israel, Italy, Japan, Kenya, Ku
- Date initiated
- 2012-07-11
- Date posted
- 2015-05-06
- Date terminated
- 2015-05-06
- 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 |