Recalls

Defective radiation device may cause suspicious scans, x-rays

A product used in radiation treatment is being recalled because the device may shed particles of chemical, known as tungsten, into the body that can show up in later scans and x-rays as suspicious calcifications.

The recall involves six lots of the Axxent FlexiShield Mini by iCad (formerly Xoft Inc.), a device that consists of a circular silicone rubber pad containing tungsten particles. The pad is placed over the surface that needs shielding from radiation therapy. It can be cut to accommodate the shape of the radiation therapy beam. It is designed to be used on the skin and to shield internal tissue from radiation therapy during Intraoperative Radiation Therapy (IORT).

The device is designed to shape a therapeutic radiation therapy beam from a low energy source to provide a means to accommodate different shapes of treatment fields. It also is used to limit the amount of radiation encountered by the skin or healthy tissue by shielding areas that do not need radiation therapy.

Testing of the Xoft Axxent Flexshield Mini led to the discovery that the device may be shedding particles of tungsten. After use for IORT in breast tissue, the particles could be mistaken for suspicious calcifications during follow up x-rays or scans.

Tungsten is not believed to be toxic and only a few health effects have been reported in patients. No permanent impairment of bodily functions or permanent damage to the body structures is anticipated.

iCad has notified its customers to remove the product and discontinue use. Consumers who have questions about their radiation treatment should contact their doctors. Any side effects should be reported to the Food and Drug Administration MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.