FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions, USA, Inc: Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system.
- Recall number
- Z-0652-2007
- Recalling firm
- Siemens Medical Solutions, USA, Inc
- Product
- Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system.
- Status
- Terminated
- Initiated
- 2007-01-31
- Posted
- 2007-03-28
- Terminated
- 2008-04-30
- Reason
- The cardiac calculation feature may incorrectly calculate a derived V max value (reported out lower than it should be) and certain values imported into worksheets and reports may be incorrect due to a software defect.
- Root cause
- Other
- Action
- Distributors were issued a recall letter dated 1/29/07 and asked to notify their customers by issuing their subaccounts a similar letter. When available, new software will be provided.
- Quantity
- 71
- Distribution
- Nationwide.
- Lot, serial or model codes
- All units. Version 5.0
- 510(k) numbers
- ["K053133"]
- 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