FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: syngo Imaging Version V31 Picture Archiving and Communication System, model number 10014063.
- Recall number
- Z-1650-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- syngo Imaging Version V31 Picture Archiving and Communication System, model number 10014063.
- Status
- Terminated
- Initiated
- 2009-06-01
- Posted
- 2009-07-07
- Terminated
- 2013-03-19
- Reason
- Risk of misinterpretation of patient response to treatment: Date displayed may be incorrect. Filtering based on examination date may lead to an incorrect list of examinations.
- Root cause
- Software design
- Action
- syngo Imaging has issued a Customer Safety Advisory Notice, dated May 28, 2009, to affected customers via Update Instruction IM019/09/S. The notice informs the customers of the potential issue and provides instructions to avoid its occurrence. A software update to correct this issue is currently being developed and will be installed on affected systems by sygo's service representatives when it becomes available.
- Quantity
- 16 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- model number 10014063. Serial numbers: 1141, 1322, 1343, 1353, 1379, 1386, 1387, 1389, 1391, 1392, 1395, 1396, 1402, 1407, 1408, and 1417
- 510(k) numbers
- ["K081734"]
- 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