FDA recall Z-2833-2018

LIEBEL-FLARSHEIM COMPANY LLC · Class II · device

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.

Reason for recall

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.

Distribution

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,

Key facts

Status
Terminated
Initiation date
2017-02-27
Report date
2018-08-29
Termination date
2023-08-16
Voluntary/Mandated
FDA Mandated
Location
Saint Louis, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2833-2018