Uroskop Omnia Max
Medical device recall Z-0806-2021. Published in FDA’s Enforcement Report on Jan 20, 2021.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 20, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 281 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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).
281, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,416 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution.
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 9, 2020.
- FDA classified it on Jan 8, 2021.
- FDA’s Enforcement Report published it on Jan 20, 2021.
- FDA terminated it on Apr 16, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Siemens Medical Solutions USA, Inc, of Malvern, PA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.