SIEMENS Healthineers Uroskop Omnia max
Medical device recall Z-2757-2020. Published in FDA’s Enforcement Report on Aug 12, 2020.
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 Aug 12, 2020. 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
- 194 units 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?
Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system under operator control with obstacles or persons .(2) Incorrectly assigned image affecting Ysio Max, Luminos dRF Max and Luminos Agile Max systems with detector MAX Static causing incorrect base for diagnosis
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
194 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 4557 4574 4571 4099 4074 4014 4627 4626 4578 4645 4316 4615 4056 4587 4049 4068 4305 4015 4543 4616 4553 4333 4063 4655 4556 4022 4521 4121 4325 4111 4510 4565 4322 4554 4301 4597 4509 4661 4036 4519 4520 4043 4024 4560…
Every code shown here, 980 characters
Serial Numbers: 4557 4574 4571 4099 4074 4014 4627 4626 4578 4645 4316 4615 4056 4587 4049 4068 4305 4015 4543 4616 4553 4333 4063 4655 4556 4022 4521 4121 4325 4111 4510 4565 4322 4554 4301 4597 4509 4661 4036 4519 4520 4043 4024 4560 4629 4530 4646 4318 4618 4575 4304 4142 4300 4095 4146 4649 4059 4562 4501 4309 4548 4313 4119 4135 4069 4020 4032 4612 4512 4053 4663 4061 4590 4593 4642 4312 4528 4060 4051 4506 4025 4037 4635 4054 4042 4033 4544 4541 4566 4132 4067 4120 4613 4112 4335 4336 4072 4652 4055 4108 4559 4511 4540 4126 4129 4104 4307 4334 4073 4631 4582 4570 4561 4641 4052 4572 4047 4134 4605 4326 4529 4603 4568 4654 4532 4102 4130 4317 4505 4062 4594 4096 4585 4637 4085 4143 4516 4662 4086 4598 4118 4573 4101 4589 4100 4321 4558 4591 4105 4106 4513 4538 4098 4537 4306 4539 4066 4310 4651 4624 4314 4545 4552 4082 4664 4125 4328 4124 4636 4329 4600 4601 4602 4094 4114 4117 4136 4303 4319 4140 4141 4500 4531 4630 4622 4535 4580 4660 4330 4332 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.
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 Jan 8, 2020.
- FDA classified it on Aug 5, 2020.
- FDA’s Enforcement Report published it on Aug 12, 2020.
- FDA terminated it on Jun 21, 2022.
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.