FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Syngo Imaging Version Lines VB20, VB30, VB35 in combination with a RIS.
- Recall number
- Z-1892-2010
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Syngo Imaging Version Lines VB20, VB30, VB35 in combination with a RIS.
- Status
- Terminated
- Initiated
- 2010-04-06
- Posted
- 2010-06-24
- Terminated
- 2012-07-05
- Reason
- Siemens has become aware of a potential malfunction and hazard to patients when using Syngo Imaging version lines VB20, VB30, VB35A in combination with a RIS that is violating DICOM Standard by creating non-unique study instance UIDs.
- Root cause
- Device Design
- Action
- The recalling firm sent a Customer Safety Advisory Notice, dated 04-06-2010, to customers explaining when the malfunction occurs and the potential risks, steps to avoid potential risk of the issue by ensuring that the RIS works according to DICOM Standard and does not create double study instance UIDs. Siemens Service Reps will contact the consignees in a timely manner to check if there are symptoms for the reported issues. The issue will be resolved with a Software-Update for each affected version, except for version VB20. All customers on VB20 will be upgraded.
- Quantity
- 3 units
- Distribution
- Nationwide Distribution -- Including CT, NM, & WI.
- Lot, serial or model codes
- Material number 10014063. Serial numbers 1043, 1114, and 1198. Version Lines VB20, VB30, & VB35.
- 510(k) numbers
- ["K082430"]
- 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