FDAMarch 11, 2021device
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
liebel flarsheimliebelliebel flarsheim
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDALiebel-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 invas...2017-02-27
- FDALiebel-Flarsheim Direct Digital Imaging System (DDIS) 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 invasiv...2017-02-27
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