medical Class II Updated 2018-08-29

LIEBEL-FLARSHEIM COMPANY LLC recalls Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR)

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Affected States: AL, AZ, CA, CT, CO, FL, GA, HI, IA, IL, ID, KS, KY, MD, MI, MN, NC, NH, NV, NY, OK, OH, PA, SC, TN, TX, VA, WA, WI, WV
Lot/Code Info: Product ID : 750732 SHF-635RF, 750733 SHF-835RF
View official government recall

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