Recall – Direct Digital Imaging System

Company: LIEBEL-FLARSHEIM COMPANY LLC
Date of Enforcement Report 8/29/2018
Class II:

PRODUCT
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.uch as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery. Recall Number: Z-2834-2018

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.

RECALLING FIRM/MANUFACTURER
LIEBEL-FLARSHEIM COMPANY LLC, St Louis, MO on 2/27/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
28

DISTRIBUTION
Nationwide

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.