SIEMENS Healthineers Uroskop Omnia max Model: 10762473 — Class II medical device recall Z-2757-2020
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2020-08-12, distributed nationwide. Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF
| Recall number | Z-2757-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2020-01-08 |
| Classified | 2020-08-05 |
| Reported by FDA | 2020-08-12 |
| Terminated | 2022-06-21 |
| Distributed | Nationwide (US) |
| Quantity | 194 units |
| Reason classes | software |
| Serial numbers | 4014, 4015, 4020, 4022, 4024, 4025, 4032, 4033, 4036, 4037, 4042, 4043, 4047, 4049, 4051, 4052, 4053, 4054, 4055, 4056, 4059, 4060, 4061, 4062, 4063 and 168 more |
| Model numbers | 10762473 |
Product
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.
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2757-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.