FDA Medical Device Recalls (openFDA)
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 number
- Z-2468-2008
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2008-08-05
- Posted
- 2008-09-29
- Terminated
- 2010-12-21
- 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
- Lot, serial or model codes
- Model numbers 07482800, 07482818, 07482826, 07478139, 07478147, and 07482479
- 510(k) numbers
- ["K052894"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 2936884
- Firm city
- Mountain View
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28