UROSKOP Omnia Max — Class II medical device recall Z-1982-2025
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2025-06-25, distributed nationwide. A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the fre
| Recall number | Z-1982-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2025-06-04 |
| Classified | 2025-06-17 |
| Reported by FDA | 2025-06-25 |
| Distributed | Nationwide (US) |
| Quantity | 25 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04056869008981 |
| 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 |
| Model numbers | 10762473 |
Product
UROSKOP Omnia Max. Model Number: 10762473
Reason for recall
A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
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-1982-2025. 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.