Reported Jul 24, 2013 · Terminated
Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic…
Leibel-Flarsheim Company LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Leibel-Flarsheim Company LLC · 2111 E Galbraith Rd · Cincinnati, OH · 45237-1624
Is this the product you have?
- Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.
- Lot codes and dates
- The following catalog numbers, serial numbers and associated manufacturing
- dates are affected by this recall
700539 CI0807H273 August2007700539 CI0106H162 January 2006700539 CI1010H523 October 2010700539 CI0811H567 August 2011700539 CI0108H313 January 2008700539 CI0309H418 March 2009700539 15031229 Apri12003700539 14031227 Apri12003700539 CI0404H045 January 2005700539 CI0504H054 May 2004700539 CI1106H208 November 2006700539 CI0509H424 May 2009
- Amount recalled
- 12 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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