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U.S. Department of Health and Human Services

Class 2 Device Recall Hydra Vision DR 60/80 System

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 Class 2 Recall
Hydra Vision DR 60/80 System
see related information
Date Posted July 18, 2013
Recall Status1 Terminated on July 26, 2013
Recall Number Z-1753-2013
Recall Event ID 65176
Premarket Notification
510(K) Number
K943581 
Product Classification Interventional Fluoroscopic X-Ray System - Product Code OWB
Product Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.
Code Information The following catalog numbers, serial numbers and associated manufacturing dates are affected by this recall: 700539 CI0807H273 August2007; 700539 CI0106H162 January 2006; 700539 CI1010H523 October 2010; 700539 CI0811H567 August 2011; 700539 CI0108H313 January 2008; 700539 CI0309H418 March 2009; 700539 15031229 Apri12003; 700539 14031227 Apri12003; 700539 CI0404H045 January 2005; 700539 CI0504H054 May 2004; 700539 CI1106H208 November 2006; 700539 CI0509H424 May 2009
Recalling Firm/
Manufacturer
Leibel-Flarsheim Company LLC
2111 E Galbraith Rd
Cincinnati, Ohio 45237-1624
Manufacturer Reason
for Recall
A complaint was received in which a hospital physicist indicated the dosage was too high on the HUT system. During the service call the systems Maximum Fluoro Dose was found to be 30 R/min which is three times the Maximum Fluoro Dose limit of 10 R/min.
FDA Determined
Cause 2
TRAINING: Employee Error
Action The customers received an "Urgent Device Correction" notification letter on May 12, 2013 explaining the product issue and providing recommended actions. Customers were contacted to set up a service call to test and recalibrate equipment as necessary. Questions were directed to 800-778-7898.
Quantity in Commerce 12 units
Distribution Nationwide Distribution (US), including the states of TN, KY, CO, KS, CT, HI, and AZ.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = OWB and Original Applicant = MALLINCKRODT GROUP, INC.
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