FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Leonardo Workstations with software versions prior to 2022A
- Recall number
- Z-1089-03
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Leonardo Workstations with software versions prior to 2022A
- Status
- Terminated
- Initiated
- 2003-02-28
- Posted
- 2003-08-07
- Terminated
- 2004-12-23
- Reason
- software problem This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment.
- Root cause
- Other
- Action
- The recalling firm issued three separate customer advisory letters dated 2/28/03, 03/01/03, and 4/14/03 to their customers explaining the problem and the preventive measure to avoid loss of information.
- Quantity
- 1374 units
- Distribution
- The product was shipped to distributors, medical facilities and Siemens training facilities nationwide.
- Lot, serial or model codes
- Model 7129534 Serial #01001 through 01380, 05001 through 05600, and 10001 through 10320
- 510(k) numbers
- ["K010938"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- 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