FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: CT syngo Dual Energy Viewer on the syngo Multimodality Work Place (MMWP) and on the CT workplace, Model number 10094833. Picture Archiving and Communications System.
- Recall number
- Z-0647-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- CT syngo Dual Energy Viewer on the syngo Multimodality Work Place (MMWP) and on the CT workplace, Model number 10094833. Picture Archiving and Communications System.
- Status
- Terminated
- Initiated
- 2008-11-13
- Posted
- 2009-01-08
- Terminated
- 2013-03-19
- Reason
- Indicated orientation does not match actual orientation of the patient.
- Root cause
- Software design
- Action
- The recalling firm issued a Customer Safety Advisory dated 10/8/08 to affected customers via Update Instructions CT052/08/S. The letter informs customers of the potential issue and provides instructions to avoid its occurrence. Customers should consider "no saving of calculated Dual Energy data sets from non-supine and mirror-option scans via "Save Sets CT"-button." The firm also highly recommends for customers "to check the correct display of "left", "anterior" and "posterior"markings, e.g. by checking the position of the spine with respect to the posterior marking in the image." The error should be fixed within certain upgrade and installation activities on the affected software.
- Quantity
- 374 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Software versions: syngo MMW 2007C, syngo MMWP 2008A, syngo MMWP 2008B, syngo MMWP 2008C, syngo CT 2007A, and syngo CT 2008G.
- 510(k) numbers
- ["K052775"]
- 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