FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions, USA, Inc: KinetDx 4.0 Ultrasound Image Management System.
- Recall number
- Z-1235-06
- Recalling firm
- Siemens Medical Solutions, USA, Inc
- Product
- KinetDx 4.0 Ultrasound Image Management System.
- Status
- Terminated
- Initiated
- 2006-04-06
- Posted
- 2006-07-13
- Terminated
- 2007-05-01
- Reason
- The cardiologist's report comments may not be retained by the system due to a software bug.
- Root cause
- Other
- Action
- In April 2006, Siemens' field force was issued instructions to visit each customer location and to complete the software upgrades within six months.
- Quantity
- 244
- Distribution
- Nationwide.
- Lot, serial or model codes
- All units with software versions 4.0 and 4.1.
- 510(k) numbers
- ["K041029"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3003304172
- Firm city
- Ann Arbor
- Firm state
- MI
- 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