FDAFDA · Food and drugs·Recall number Z-1753-2013
Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.
Published July 24, 2013 · Recall initiated: April 25, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Leibel-Flarsheim Company LLC
- Distributor
- Nationwide Distribution (US), including the states of TN, KY, CO, KS, CT, HI, and AZ.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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