FDAFDA · Food and drugs·Recall number Z-1982-2025
UROSKOP Omnia Max. Model Number: 10762473
Published June 25, 2025 · Recall initiated: June 4, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- Nationwide distribution.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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