Recall Z-1981-2025— Siemens Medical Solutions USA, Inc
Class II · Ongoing
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2025-06-04. It names 2 FDA 510(k) clearances: K173639, K101491. Product: UROSKOP Omnia. Model Number: 10094910. Reason: A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-06-04
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
2 on FDA's record- K173639 — Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax
- K101491 — UROSKOP OMNIA
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.