FDA Device recall Z-2853-2016
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, commun…
- FDA Device
- Class II
- terminated
- Published 2016-09-28
On 2016-09-28 the FDA classified a Class II recall of Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, commun… by Siemens Medical Solutions Usa, citing software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2853-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-05 |
| Published | 2016-09-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
Reason
Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high.
Identifiers
| code_info | Serial Numbers: 220755 101060 220807 221363 220497 221053 100662 130301 101494 130643 101312 310364 102213…Serial Numbers: 220755 101060 220807 221363 220497 221053 100662 130301 101494 130643 101312 310364 102213 221225 130653 220687 220811 310395 102048 100741 102523 101739 221244 102125 102401 310397 102036 220939 100915 221110 100598 130765 130321 130118 310310 102477 130692 102008 130159 101757 101773 100751 100713 101802 102535 310536 221199 102089 220451 101559 101479 130252 100417 100421 100641 100642 100644 100646 100418 100419 100420 100643 100645 100811 100812 100813 100814 102369 101521 221129 310363 220909 400047 100669 130326 101839 311011 130712 131011 101027 100744 130784 310524 311001 101313 101233 101114 221192 130201 130180 220604 100518 100735 102296 130629 102532 102158 101843 102447 102533 220930 102515 220684 220725 130908 102271 130309 102265 101638 102449 102377 102553 130396 101864 101826 102563 102374 100704 102340 310365 310388 102197 101938 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2853-2016%22
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