FDA Device recall Z-1181-2013
Vitrea¿ CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise…
- FDA Device
- Class II
- terminated
- Published 2013-05-08
On 2013-05-08 the FDA classified a Class II recall of Vitrea¿ CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise… by Vital Images, citing vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing a brain perfusion scan on Vitrea CT Brain Perfusion 2D when the scan was performe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1181-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-15 |
| Published | 2013-05-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Vital Images |
| Distribution | DC, GA, PR, RI, SD |
Product
Vitrea¿ CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite. Noninvasive post-processing application designed to evaluate areas of brain perfusion.
Reason
Vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing a brain perfusion scan on Vitrea CT Brain Perfusion 2D when the scan was performed using a wide coverage shuttle acquisition technique. This may result in patient treatment delays, misdiagnosis or mistreatment.
Identifiers
| code_info | Versions 6.0 and above. Serial Numbers: VPE0503066 VPE0911551 VPE0908462 324112 VPE0503082 VPE0707078 VPE…Versions 6.0 and above. Serial Numbers: VPE0503066 VPE0911551 VPE0908462 324112 VPE0503082 VPE0707078 VPE0707079 5040227558 5040227590 VPE0503081 VPE0609168 5040227140 VPE0707067 VPE1006732 VPE1011765 VPE0707087 5080113685 VPE0802171 VPE0805209 VPE0805281 VPE0902329 475604 5080121211 357678 5080119381 395647 5090112096 449462 VPE1003630 5090102007 VPE0502007 VPE0602118 VPE0602122 VPE0602117 N/A N/A VPE0503073 475635 5090111480 5090111472 5040227329 5031211482 5040919344 VPE0602131 5080117869 5090111960 373409 5090103704 VESADLCC1206033 5090102775 N/A VPE0503080 5080121653 VPE1211025 5080117230 5030861645 5090104980 470268 5090102848 5080116463 VPE0503068 VPE0707080 VPE0707074 5040227507 5080116269 VPE0503048 5090114366 VPE0710133 5080116382 5080115025 5090110263 VPE0503079 VPE1006755 VPE0503052 5040919425 5090103755 VPE0502024 5040919263 5080119233 VPE0503046 VPE0503059 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1181-2013%22
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