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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 Systemsee related information
Date Initiated by FirmMarch 11, 2021
Create DateJuly 02, 2021
Recall Status1 Terminated 3 on September 18, 2024
Recall NumberZ-1992-2021
Recall Event ID 88195
510(K)NumberK121838 
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
ProductHydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Code Information Product ID/Reorder Number: 705559 (65KW), 705560 (80KW) Model/NDC: HUTSHVDIS 
FEI Number 3012465398
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
ActionThe 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 Commerce17
DistributionUS Nationwide Distribution and in the country of Canada
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MQB
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