Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hydra Vision DR 60/80 System Recalled by Leibel-Flarsheim Company LLC Due to A complaint was received in which a hospital...
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 Leibel-Flarsheim Company LLC directly.
Affected Products
Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.
Quantity: 12 units
Why Was This Recalled?
A complaint was received in which a hospital physicist indicated the dosage was too high on the HUT system. During the service call the systems Maximum Fluoro Dose was found to be 30 R/min which is three times the Maximum Fluoro Dose limit of 10 R/min.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Leibel-Flarsheim Company LLC
Leibel-Flarsheim Company LLC has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report