ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usa
FDA device recall Z-1581-2015 · posted 2015-05-05 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- In some cases, the system is unable to capture a clip or image during a routine scan.
- Action taken
- Siemens sent a Customer Advisory Notice letter to affected customers. The letter identified the affected product. problem and how this issue is being resolved. To resolve this issue on all affected systems, a mandatory software update has been developed and is being installed free of charge.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 186 devices
- Distribution
- Worldwide Distribution - US Nationwide and the countries of:Angola, Armenia, Australia, Austria, Belgium, Bosnia Herzeg., Brazil, Brunei, Bulgaria, Colombia, Czech Republic, Finland, France, Germany,
- Date initiated
- 2012-05-11
- Date posted
- 2015-05-05
- 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 |