FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions, USA, Inc: Siemens syngo Dynamics Workplace, version 6.0, Siemens Medical Solutions, Ann Arbor, MI; 10090334. Intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
- Recall number
- Z-0545-2009
- Recalling firm
- Siemens Medical Solutions, USA, Inc
- Product
- Siemens syngo Dynamics Workplace, version 6.0, Siemens Medical Solutions, Ann Arbor, MI; 10090334. Intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
- Status
- Terminated
- Initiated
- 2008-07-23
- Posted
- 2009-01-02
- Terminated
- 2010-10-18
- Reason
- If the text is manually modified and additional phrases added as a result of worksheet interactions, some of the phrases may not populate the report.
- Root cause
- Software design
- Action
- Consignees were notified of the problem via a Customer Safety Advisory Notice dated 7/23/08, which provided guidance on how to minimize the risk of the problem occurring, and told customers that a service patch will be installed when it becomes available.
- Quantity
- 306 of all products.
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- All units.
- 510(k) numbers
- ["K070322"]
- 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