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U.S. Department of Health and Human Services

Class 2 Device Recall LiebelFlarsheim Direct Digital Imaging System (DDIS)

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  Class 2 Device Recall LiebelFlarsheim Direct Digital Imaging System (DDIS) see related information
Date Initiated by Firm February 27, 2017
Create Date August 21, 2018
Recall Status1 Terminated 3 on August 16, 2023
Recall Number Z-2834-2018
Recall Event ID 80174
510(K)Number K121838  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
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.
Code Information Product ID 750736 SHF-635RF, 750737 SHF-835RF
Recalling Firm/
Manufacturer		 LIEBEL-FLARSHEIM COMPANY LLC
1034 S Brentwood Blvd
Saint Louis MO 63117-1223
For Additional Information Contact
314-376-4768
Manufacturer 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.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action The firm, Liebel-Flarsheim, notified its customers by phone on or about 2/27/2017 to inform them of the product, problem and actions to be taken. The firm plans to have these Sedecal software updates implemented over the course of the next 12 months. For additional information, please contact me at 314-376-4788.
Quantity in Commerce 28
Distribution 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,
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = LIEBEL-FLARSHEIM
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