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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Siemens Medical Solutions USA, Inc.
Lot Codes / Batch Numbers
Model numbers 07482800, 07482818, 07482826, 07478139, 07478147, and 07482479
Products Sold
Model numbers 07482800, 07482818, 07482826, 07478139, 07478147, and 07482479
Siemens Medical Solutions USA, Inc. is recalling Sonoline G50/G60 Ultrasound System, Software versions 1.0.0 to 1.5.0b. The product is a general pur due to As a result of bugs and calculation errors, the system may display incorrect or fail to display mechanical Index and thermal index values.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
As a result of bugs and calculation errors, the system may display incorrect or fail to display mechanical Index and thermal index values.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026