FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Leonardo MM-WS systems. System, Image Processing.
- Recall number
- Z-0841-03
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Leonardo MM-WS systems. System, Image Processing.
- Status
- Terminated
- Initiated
- 2002-10-11
- Posted
- 2003-05-16
- Terminated
- 2006-10-03
- Reason
- Perfusion CT is displaying a higher gray and color values than normal. A software problem.
- Root cause
- Other
- Action
- Update instructions on the new software were sent to the three customers on 8/2/2002. This update was followed up by a service representative to actually install the software.
- Quantity
- 2
- Distribution
- The product was distributed to three hospitals: Cleveland Clinic Foundation, Cleveland, OH; Brigham & Womens Hospital, Boston, MA; and Barnes Jewish Hosp. South Campus, Saint Louis, MO.
- Lot, serial or model codes
- Model Number 7129534
- 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