Liebel-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 invasive urology/ surgery.

Reason: 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.

Code information: Product ID 750736 SHF-635RF, 750737 SHF-835RF

Distribution pattern: US Distribution to: AL, AZ, CA, CT, CO, FL GA, HI, IA, IL, ID, KS, KY, MD, MI, Michigan, MN, NC, NH, NV, NY, OK, OH, PA, SC, TN, TX, VA, WA, WI, and WV,