Siemens Uroskop Omnia X-ray System Recall: Support Arm Dislodgement Risk
Siemens recalls Uroskop Omnia model 10094910 X-ray systems due to risk of support arm dislodging after prolonged intense use. Affected units have specific serial numbers.
Use caution until it’s fixed
After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely over a long period of time.
Contact the company
What happened, in plain English
Siemens is recalling Uroskop Omnia X-ray systems that could have a support arm that becomes dislodged after long periods of heavy use. This could lead to injury if the arm moves unexpectedly during medical procedures. Read more at govinfonow.com/recall/64316-siemens-uroskop-omnia-x-ray-system-recall-support-arm-dislodgement.
Source Summary by GovInfoNow · govinfonow.com/recall/64316-siemens-uroskop-omnia-x-ray-system-recall-support-arm-dislodgement · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0805-2021
Cite this page
“Siemens Uroskop Omnia X-ray System Recall: Support Arm Dislodgement Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64316-siemens-uroskop-omnia-x-ray-system-recall-support-arm-dislodgement. Based on FDA recall #Z-0805-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0805-2021%22&limit=1).
Why it’s dangerous
The support arm can become dislodged after prolonged intense use, which might cause it to move unexpectedly during medical procedures. This could lead to injury to the patient or healthcare provider.
Who’s affected
Healthcare professionals using the Uroskop Omnia X-ray system for urological procedures are most at risk. Patients undergoing these procedures may also be affected if the system malfunctions.
How to tell if you have this one
Check for the model number 10094910 on the Uroskop Omnia X-ray system. Affected units have specific serial numbers: 3417, 3414, 3415, 3418, 3428, 3416.
- Brand
Siemens- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide distribution.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0805-2021 | Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).; Serial Nos. 3417 3414 3415 3418 3428 3416 | 6 |
| Z-0806-2021 | Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).; Serial Nos. 4557 4574 4571 4099 5051 5135 5173 5061 5193 5214 4627 4626 5072 5215 5030 4578 4645 4316 4615 4056 4587 4049 5184 4305 5045 5095 4543 4616 5062 4553 4333 4063 5200 4655 4556 4521 4121 4325 4111 4510 5188 5199 4565 4322 4554 4301 4597 4509 4661 5118 4036 5137 4519 4520 5058 4043 5116 4560 5093 4629 5134 4530 4646 5094 5067 4318 4618 4575 5090 5049 4300 4095 4146 4649 5194 4059 5070 4562 4501 4309 4548 4313 4119 4135 4069 4032 4612 4512 4053 5123 4663 5106 5144 4061 5064 4590 4593 5176 5066 4642 5060 4312 4528 4060 5174 4051 4506 4037 5057 4635 5163 4054 5133 4042 4033 4544 4566 4132 4067 4120 5198 4613 4112 4335 4336 5108 5038 5150 4072 4652 5196 5026 4055 5059 4108 4559 5088 5128 5074 4511 5020 4126 5219 4129 4104 5130 4307 5104 4334 5085 5023 5027 5021 4073 4631 4582 4570 5187 4561 5069 5208 4641 4052 4572 5033 4047 4134 4605 4326 5168 5139 5140 4603 5117 4568 4654 4532 5211 5190 4304 4142 4038 5086 5192 4102 4130 5043 4317 5099 4505 4062 5181 5152 4594 5146 5084 4096 5172 5114 5186 5164 4585 5183 4637 5025 4085 4143 4516 4662 4086 4598 4118 4573 5175 4101 4589 4100 5087 4321 4558 4591 4105 4106 4513 4098 5055 4306 4066 4310 5107 5143 4651 4624 4314 4545 4552 4082 5101 4664 4125 4328 5191 4124 5078 5159 5103 4636 4329 4128 4600 4601 4602 4659 4094 4114 4117 4136 4303 4319 5028 5122 5142 4140 4141 4500 5222 4531 4630 5124 4622 4535 4580 4660 5155 5201 4330 4332 5112 4133 4588 4609 | 281 |
What to do — step by step
Check Support Arm Condition
Inspect the support arm for signs of dislodgement after prolonged heavy use, especially if the system has been used intensively over time.
How this recall unfolded
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0805-2021 (September 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0805-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.