UROSKOP Omnia Max. Model Number: 10762473 recallZ-1982-2025 · Siemens Medical Solutions USA, Inc · initiated Jun 4, 2025

Why it was recalled

A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.

FDA root cause category: Device Design

What the company is doing

Siemens notified consignees on about 06/04/2025 via letter. Consignees were instructed that they can continue to use their system when paying attention for signs of burning smell and/or smoke coming from the device base. In this case, the system must be immediately disconnected from power supply via room emergency on/off switch and the Siemens Healthineers Service Organization must be informed. Siemens Healthineers is preparing an on-site field safety corrective action to replace the frequency inverter by another type that cannot cause the described problem. The field safety corrective action will be implemented in the second quarter of 2025 with update XP008/25/S and will be provided to you free of charge. Consignees were instructed to ensure that all affected personnel are informed as well as any customers if the unit was further distributed and to acknowledge receipt of the recall notification.

Recall details

Recall number

Z-1982-2025

Status

Open, Classified

Initiated by the company

Jun 4, 2025

Posted by the FDA

Jun 17, 2025

Recalling firm

Siemens Medical Solutions USA, Inc

Quantity

25 units

Product code

JAA

FDA submissions

K101491, K173639

Distribution

Nationwide distribution.

Product description

UROSKOP Omnia Max. Model Number: 10762473

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Uroskop Omnia Max 10762473

  Siemens Healthcare GmbH · System, x-ray, fluoroscopic, image-intensified
  2 recalls8 reports

Other devices under the same FDA submission

2 devices cleared under K101491, K173639 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• LUMINOS Lotus Max 11574100

  Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system
  2 recalls7 reports
• Multitom Rax 10860700

  Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system
  3 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 97050).

• Z-1981-2025 · Open, Classified
  UROSKOP Omnia. Model Number: 10094910