Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems Recalled by LIEBEL-FLARSHEIM COMPANY LLC Due to Software issue. The difference between the display and...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact LIEBEL-FLARSHEIM COMPANY LLC directly.
Affected Products
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.
Quantity: 313
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 30 states: AL, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IA, KS, KY, MD, MI, MN, NV, NH, NY, NC, OH, OK, PA, SC, TN, TX, VA, WA, WV, WI
About LIEBEL-FLARSHEIM COMPANY LLC
LIEBEL-FLARSHEIM COMPANY LLC has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report