FDA Recalls Radiation Shield That Sheds Tungsten

Law360, New York (April 14, 2011, 5:26 PM EDT) -- The U.S. Food and Drug Administration announced a recall Wednesday of a radiation therapy shield manufactured by Xoft Inc. that may shed tungsten particles into women’s breasts.

The device, known as the Axxent Flexishield Mini, was originally taken off the market in February, prompting at least a couple of product liability suits in California state court. But now the FDA has upgraded the situation to a Class I recall for products that could cause serious health problems or death.

Xoft has conducted laboratory tests and a...
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