LIEBEL-FLARSHEIM COMPANY LLC: Medical Device Recall in 2018 - (Recall #: Z-2834-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 27, 2017

Date Posted: August 29, 2018

Recall Number: Z-2834-2018

Event ID: 80174

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.

Status: Terminated

Product Quantity: 28

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,

Voluntary or Mandated:

FDA Mandated