Z-1981-2025 Class II Ongoing

Recalled by Siemens Medical Solutions USA, Inc — Malvern, PA

Recall Details

Product Type
Devices
Report Date
June 25, 2025
Initiation Date
June 4, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
95 units

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.

Distribution Pattern

Nationwide distribution.

Code Information

Model Number: 10094910. No UDI. Serial Numbers: 3054, 3029, 3062, 3169, 3402, 3103, 3053, 3055, 3072, 3019, 3048, 3403, 3058, 1045, 2014, 3091, 3013, 3023, 3115, 3051, 3417, 3160, 2033, 3163, 3052, 3166, 3099, 3138, 3157, 3038, 3131, 3037, 3117, 3118, 3096, 3123, 3124, 2022, 2032, 2031, 3134, 3106, 3415, 3042, 3014, 3012, 3108, 3105, 3057, 2008, 3122, 3034, 3151, 3414, 2030, 3021, 3119, 3086, 3073, 3089, 3036, 3031, 3409, 3064, 3153, 3095, 3145, 3079, 3017, 3025, 3076, 2046, 2047, 2055, 2054, 2049, 3416, 2015, 1041, 3155, 3418, 3081, 3084, 2045, 3015, 3125, 3132, 3143, 3085, 3405, 2041, 2009, 3410, 2029, 3404.