Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW) Recalled by LIEBEL-FLARSHEIM COMPANY LLC Due to Failure to comply with the performance standard for...
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
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Quantity: 17
Why Was This Recalled?
Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual values by more than ¿ 35 percent. The dosage displayed on the generator console and table display (monitor) is higher than the actual delivered dose.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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