Sonoline G50/G60 Ultrasound System, Software versions 1.0.0 to 1.5.0b. The product is a general purpose, mobile software
FDA device recall Z-2468-2008 · posted 2008-09-29 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- As a result of bugs and calculation errors, the system may display incorrect or fail to display mechanical Index and thermal index values.
- Action taken
- The firm initiated its field correction on 08/05/2008. The firm's service personnel will make site visits to correct the problem and install the revised software (version 1.5.0c). Contact Siemens Medical Solutions USA, Inc. at 1-650-694-5993 for assistance.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 2541 units
- Distribution
- Worldwide
- Date initiated
- 2008-08-05
- Date posted
- 2008-09-29
- Date terminated
- 2010-12-21
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SONOLINE G60 S ULTRASOUND SYSTEM (K052894) | Siemens Medical Solutions USA, Inc. | 2005-11-23 |