Uroskop Omnia Max -fluoroscopic X-ray system
Medical device recall Z-0985-2019. Published in FDA’s Enforcement Report on Mar 13, 2019.
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 Mar 13, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 191 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?
The swivel arm holding the monitors may become dislodged from the carrying arm.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
191, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 4032 4033 4036 4037 4038 4042 4043 4047 4052 4053 4054 4055 4056 4059 4060 4061 4063 4066 4069 4072 4073 4082 4085 4086 4094 4095 4096 4098 4099 4100 4101 4102 4104 4108 4111 4112 4114 4117 4118 4119 4120 4121 4124 4125…
Every code shown here, 970 characters
Serial Numbers: 4032 4033 4036 4037 4038 4042 4043 4047 4052 4053 4054 4055 4056 4059 4060 4061 4063 4066 4069 4072 4073 4082 4085 4086 4094 4095 4096 4098 4099 4100 4101 4102 4104 4108 4111 4112 4114 4117 4118 4119 4120 4121 4124 4125 4126 4128 4129 4130 4132 4133 4134 4135 4136 4140 4141 4142 4143 4146 4300 4301 4303 4304 4305 4306 4309 4310 4312 4313 4314 4317 4318 4319 4321 4322 4325 4326 4328 4329 4330 4332 4333 4334 4500 4501 4505 4506 4509 4510 4511 4513 4516 4519 4520 4521 4528 4529 4530 4531 4532 4543 4544 4545 4548 4552 4553 4556 4557 4558 4559 4560 4561 4562 4565 4566 4568 4571 4572 4573 4574 4575 4578 4582 4585 4587 4588 4589 4590 4591 4593 4594 4597 4598 4600 4601 4602 4603 4605 4609 4613 4615 4616 4618 4622 4624 4626 4627 4629 4630 4631 4635 4636 4637 4641 4642 4645 4646 4649 4651 4652 4655 4659 4661 4662 4663 4664 5020 5021 5023 5025 5026 5027 5028 5030 5031 5033 5038 5043 5045 5051 5057 5058 5059 5060 5061 5066 5067 5069 5070 5072 5074 5078
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.
US Nationwide Distribution
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 Feb 8, 2019.
- FDA classified it on Mar 7, 2019.
- FDA’s Enforcement Report published it on Mar 13, 2019.
- FDA terminated it on May 5, 2020.
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
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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.