FDA Device recall Z-1982-2025
UROSKOP Omnia Max
- FDA Device
- Class II
- ongoing
- Published 2025-06-25
On 2025-06-25 the FDA classified a Class II recall of UROSKOP Omnia Max by Siemens Medical Solutions Usa, citing A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1982-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-04 |
| Published | 2025-06-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
UROSKOP Omnia Max. Model Number: 10762473
Reason
A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
Identifiers
| code_info | Model Number: 10762473. UDI Numbers: (01)04056869008981(21)4014, (01)04056869008981(21)4056, (01)04056869008981(21)4049…Model Number: 10762473. UDI Numbers: (01)04056869008981(21)4014, (01)04056869008981(21)4056, (01)04056869008981(21)4049, (01)04056869008981(21)4015, (01)04056869008981(21)4063, (01)04056869008981(21)4022, (01)04056869008981(21)4036, (01)04056869008981(21)4043, (01)04056869008981(21)4024, (01)04056869008981(21)4059, (01)04056869008981(21)4020, (01)04056869008981(21)4032, (01)04056869008981(21)4053, (01)04056869008981(21)4061, (01)04056869008981(21)4060, (01)04056869008981(21)4051, (01)04056869008981(21)4025, (01)04056869008981(21)4037, (01)04056869008981(21)4054, (01)04056869008981(21)4042, (01)04056869008981(21)4033, (01)04056869008981(21)4055, (01)04056869008981(21)4052, (01)04056869008981(21)4047, (01)04056869008981(21)4062. Serial Numbers: 4014, 4056, 4049, 4015, 4063, 4022, 4036, 4043, 4024, 4059, 4020, 4032, 4053, 4061, 4060, 4051, 4025, 4037, 4054, 4042, 4033, 4055, 4052, 4047, 4062. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1982-2025%22
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