FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Syngo.via. Medical Device Software. Picture archiving and communications system.
- Recall number
- Z-1303-2018
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Syngo.via. Medical Device Software. Picture archiving and communications system.
- Status
- Terminated
- Initiated
- 2018-01-08
- Posted
- 2018-03-20
- Terminated
- 2020-04-22
- Reason
- A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving corrected/modified values. Outdated information could be sent to the referring physician when creating the formal report in the reporting system.
- Root cause
- Software design
- Action
- Customer Advisory Notice SY065/17/P was sent to direct accounts. Firm is continuing to work on software solution. A workaround is available and is described in the Customer Advisory Notice.
- Quantity
- 236 units
- Distribution
- Device is software only. No products are distributed to wholesale dealers, distributers or retailers
- Lot, serial or model codes
- Model Number 10496180
- 510(k) numbers
- ["K123375"]
- 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