FDA Device recall Z-1165-2023
Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472
- FDA Device
- Class II
- ongoing
- Published 2023-03-01
On 2023-03-01 the FDA classified a Class II recall of Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472 by Siemens Medical Solutions Usa, citing potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1165-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-21 |
| Published | 2023-03-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472
Reason
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values
Identifiers
| code_info | UDI: N/A Serial Number 61624 61652 61659 63243 63344 64145 61664 61641 61631 61148 61171 61224 61776 61186 61014 61189…UDI: N/A Serial Number 61624 61652 61659 63243 63344 64145 61664 61641 61631 61148 61171 61224 61776 61186 61014 61189 61142 61718 61036 61857 63268 61775 61078 61216 61818 61629 61067 63350 Expanded Recall 2/24/23: 61017 61021 61031 61033 61034 61037 61038 61040 61041 61045 61047 61055 61057 61059 61063 61065 61073 61074 61075 61077 61083 61094 61096 61097 61098 61099 61100 61101 61102 61112 61118 61120 61123 61125 61126 61129 61130 61131 61132 61133 61143 61152 61153 61157 61158 61160 61164 61165 61166 61168 61172 61174 61175 61177 61178 61184 61185 61191 61193 61195 61202 61203 61205 61208 61209 61210 61220 61224 61226 61230 61233 61237 61243 61245 61253 61258 61604 61606 61612 61616 61617 61618 61626 61632 61633 61639 61640 61649 61653 61654 61655 61657 61662 61664 61665 61666 61667 61671 61672 61675 61676 61678 61683 61687 61691 61700 61702 61704 61707 61708 61710 61719 61723 61724 61725 61729 61734 61736 61740 61746 61751 61753 61754 61756 61758 61761 61764 61765 61769 61772 6177 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1165-2023%22
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