FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Syngo.plaza, picture archiving and communications system.
- Recall number
- Z-1116-2017
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Syngo.plaza, picture archiving and communications system.
- Status
- Terminated
- Initiated
- 2017-01-11
- Posted
- not on file
- Terminated
- 2017-11-16
- Reason
- Software update for improvements and to resolve several issues
- Root cause
- Under Investigation by firm
- Action
- Siemens mailed a Customer Letter to affected customers on 01/13/2017 to provide information about the latest software change that is now available to address several issues.
- Quantity
- 62 systems
- Distribution
- Distributed throughout the United States.
- Lot, serial or model codes
- Model Number: 10863171, 10863172, 10863173 Serial Numbers: 100262 100198 100258 100259 100135 100538 100133 100031 100105 100106 100109 100110 100111 100112 100113 100114 100115 100116 100117 100119 100120 100416 100461 100245 100447 100364 100298 100299 100386 100139 100027 100440 100441 100559 100025 100033 100196 100189 100190 100191 100192 100195 100186 100232 100450 100449 100256 100199 100188 100194 100198 100029 100253 100203 100204 100132 100139 100434 100476 100495 100491 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