FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Syngo.plaza, Picture Archiving and Communication System
- Recall number
- Z-2891-2016
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Syngo.plaza, Picture Archiving and Communication System
- Status
- Terminated
- Initiated
- 2016-09-06
- Posted
- 2016-09-27
- Terminated
- 2017-05-08
- Reason
- Software upgrade to eliminate several issues
- Root cause
- Software design
- Action
- Siemens notified customers via mail on 09/07/2016 informing them of the latest syngo.plaza software change that was available to address several issues.
- Quantity
- 47 systems
- Distribution
- Distributed Nationwide
- Lot, serial or model codes
- Serial Numbers: 100262 100198 100258 100259 100538 100133 100213 100214 100031 100484 100362 100416 100461 100457 100447 100139 100027 100559 100440 100441 100025 100084 100186 100189 100190 100191 100192 100195 100196 100033 100232 100449 100450 100199 100256 100228 100425 100029 100253 100203 100204 100132 100434 100491 100495 100206
- 510(k) numbers
- ["K093612"]
- 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