FDA Device recall Z-1168-2023
Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473
- FDA Device
- Class II
- ongoing
- Published 2023-03-01
On 2023-03-01 the FDA classified a Class II recall of Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473 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-1168-2023 |
| 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
Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473
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: 4056869008981 S/N: 4645 4556 4510 5144 4307 4594 4125 Expanded Recall 2/24/23: 4014 4015 4020 4022 4032 4033 4…UDI: 4056869008981 S/N: 4645 4556 4510 5144 4307 4594 4125 Expanded Recall 2/24/23: 4014 4015 4020 4022 4032 4033 4042 4047 4055 4059 4061 4062 4063 4067 4068 4086 4094 4096 4099 4102 4105 4106 4108 4111 4112 4114 4117 4119 4120 4126 4128 4129 4130 4132 4134 4135 4136 4141 4142 4146 4303 4305 4306 4310 4312 4314 4316 4318 4319 4325 4326 4329 4330 4332 4500 4501 4509 4513 4516 4519 4520 4529 4531 4532 4535 4537 4538 4540 4541 4543 4544 4548 4552 4553 4554 4557 4559 4561 4562 4565 4566 4570 4575 4580 4582 4585 4587 4588 4591 4593 4597 4600 4601 4602 4603 4605 4609 4616 4626 4627 4629 4630 4631 4635 4636 4637 4641 4651 4659 4660 5026 5028 5030 5031 5033 5049 5051 5061 5062 5064 5066 5069 5072 5074 5078 5084 5088 5093 5101 5103 5107 5108 5112 5114 5116 5118 5123 5124 5128 5130 5133 5134 5135 5137 5139 5140 5142 5146 5152 5159 5163 5173 5174 5175 5186 5187 5190 5191 5196 5197 5198 5199 5208 5215 5221 5222 5232 5240 5258 5267 5268 5278 6013 6021 6023 6034 6035 6038 6039 6043 6044 6048 60 |
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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-1168-2023%22
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