FDA Medical Device Recalls (openFDA)
LIEBEL-FLARSHEIM COMPANY LLC: Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery.
- Recall number
- Z-2833-2018
- Recalling firm
- LIEBEL-FLARSHEIM COMPANY LLC
- Product
- Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery.
- Status
- Terminated
- Initiated
- 2017-02-27
- Posted
- not on file
- Terminated
- 2023-08-16
- Reason
- Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes deviated by less than 35% from the dosimeter readings.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- The firm, Liebel-Flarsheim, notified its customers by phone on or about 2/27/2017 to inform them of the product, problem and actions to be taken. The firm plans to have these Sedecal software updates implemented over the course of the next 12 months. For additional information, please contact me at 314-376-4788.
- Quantity
- 313
- Distribution
- US Distribution to: AL, AZ, CA, CT, CO, FL GA, HI, IA, IL, ID, KS, KY, MD, MI, Michigan, MN, NC, NH, NV, NY, OK, OH, PA, SC, TN, TX, VA, WA, WI, and WV,
- Lot, serial or model codes
- Product ID : 750732 SHF-635RF, 750733 SHF-835RF
- 510(k) numbers
- ["K943581"]
- PMA numbers
- not on file
- Product code
- IXR
- Firm FEI
- 3012465398
- Firm city
- Saint Louis
- Firm state
- MO
- 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