Recall – Liebel-Flarsheim Hydra Vision Urology X-Ray Cl II

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

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.
Recall Number: Z-2833-2018

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
313

DISTRIBUTION
Nationwide

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Corporate Office

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