Recall Z-2468-2008 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
Sonoline G50/G60 Ultrasound System, Software versions 1.0.0 to 1.5.0b. The product is a general purpose, mobile software controlled diagnostic ultrasound system.
| Date | Sep 29, 2008 (initiated Aug 5, 2008) |
| Status | Terminated |
| Reason | As a result of bugs and calculation errors, the system may display incorrect or fail to display mechanical Index and thermal index values. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 2541 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052894 | SONOLINE G60 S ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc., Nov 23, 2005 |