FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
- Recall number
- Z-0984-2019
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
- Status
- Terminated
- Initiated
- 2019-02-08
- Posted
- not on file
- Terminated
- 2020-05-05
- Reason
- The swivel arm holding the monitors may become dislodged from the carrying arm.
- Root cause
- Device Design
- Action
- The firm, Siemens, issued an "URGENT: MEDICAL DEVICE CORRECTION "on 2/8/19 to its customers. The letter is identifying the problem, risk, actions to take and corrective action. The customers were instructed to do the following: Immediately examine your inventory and quarantine product subject to recall (if applicable). or To avoid the risk until implementation of the corrective action, it is strongly recommended not to move and position monitors above the system table. As an alternative and if clinically applicable, monitors can also be used when they are left in the parking position. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. If the device has been sold and is therefore no longer in your possession, please forward this notice to the new owner. The service organization will contact and arrange a date to perform this corrective action with Updated Instruction XP006/19/S. Contact the service organization for an earlier appointment at 1-800-888-7436.
- Quantity
- 6
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Serial Numbers: 3414 3415 3416 3417 3418 3428
- 510(k) numbers
- ["K101491"]
- 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