29
Aug
2018

Recall – Direct Digital Imaging System

,
0

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

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