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U.S. Department of Health and Human Services

Class 2 Device Recall HydraVision Digital Imaging System

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  Class 2 Device Recall HydraVision Digital Imaging System see related information
Date Initiated by Firm March 11, 2021
Create Date July 02, 2021
Recall Status1 Open3, Classified
Recall Number Z-1992-2021
Recall Event ID 88195
510(K)Number K121838  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product HydraVision Digital Imaging System
Product ID/Reorder Number: 705559 (65KW)
Code Information Product ID/Reorder Number: 705559 (65KW), 705560 (80KW) Model/NDC: HUTSHVDIS 
Recalling Firm/
Manufacturer		 LIEBEL-FLARSHEIM COMPANY LLC
1034 S Brentwood Blvd
Saint Louis MO 63117-1223
For Additional Information Contact
513-446-6153
Manufacturer Reason
for Recall		 Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual values by more than ¿ 35 percent. The dosage displayed on the generator console and table display (monitor) is higher than the actual delivered dose.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action The product can be brought into compliance via a software update. The firm plan to have the updated software installed, working with customer schedules, over the course of the next 12 months.
Quantity in Commerce 17
Distribution US Nationwide Distribution and in the country of Canada
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = LIEBEL-FLARSHEIM
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