Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop… — Class II medical device recall Z-0985-2019
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2019-03-13, distributed nationwide. The swivel arm holding the monitors may become dislodged from the carrying arm.
| Recall number | Z-0985-2019 |
|---|---|
| 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 | 2019-02-08 |
| Classified | 2019-03-07 |
| Reported by FDA | 2019-03-13 |
| Terminated | 2020-05-05 |
| Distributed | Nationwide (US) |
| Quantity | 191 |
| 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 and 166 more |
| Model numbers | 10762473 |
Product
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.
Reason for recall
The swivel arm holding the monitors may become dislodged from the carrying arm.
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-0985-2019. 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.