Uroskop Omnia Max — Class II medical device recall Z-0806-2021
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2021-01-20. After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm
| Recall number | Z-0806-2021 |
|---|---|
| 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 | 2020-09-09 |
| Classified | 2021-01-08 |
| Reported by FDA | 2021-01-20 |
| Terminated | 2021-04-16 |
| Quantity | 281 |
| Serial numbers | 4032, 4033, 4036, 4037, 4038, 4042, 4043, 4047, 4049, 4051, 4052, 4053, 4054, 4055, 4056, 4059, 4060, 4061, 4062, 4063, 4066, 4067, 4069, 4072, 4073 and 256 more |
| Model numbers | 10762473 |
Product
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).
Reason for recall
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.
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-0806-2021. 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.