FDAFebruary 27, 2017device
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 invas...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
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.
- FDAHydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)2021-03-11
- 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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