FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: UROSKOP Omnia Max. Model Number: 10762473
- Recall number
- Z-1982-2025
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- UROSKOP Omnia Max. Model Number: 10762473
- Status
- Open, Classified
- Initiated
- 2025-06-04
- Posted
- 2025-06-17
- Terminated
- not on file
- Reason
- A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 25 units
- Distribution
- Nationwide distribution.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K101491","K173639"]
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28