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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Event Detail

Event ID 65176
Product Type Devices
Status Ongoing
Recalling Firm Leibel-Flarsheim Company LLC
City Cincinnati
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-25
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution (US), including the states of TN, KY, CO, KS, CT, HI, and AZ.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures. 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 Class II 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. 12 units Z-1753-2013