FDA recall Z-1981-2025
Siemens Medical Solutions USA, Inc · Class II · device
Product
UROSKOP Omnia. Model Number: 10094910
Reason for recall
A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
Distribution
Nationwide distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2025-06-04
- Report date
- 2025-06-25
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Malvern, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1981-2025