Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 invasi — recall Z-2834-2018

U.S. FDA — Device Enforcement · United States · 2017-02-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2834-2018
Date of alert: 2017-02-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: LIEBEL-FLARSHEIM COMPANY LLC
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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