Axxent FlexiShield Mini by iCAD (formerly Xoft Inc.): Recall - Product May Shed Particles of Tungsten
MedSun: Newsletter #60, May 2011

FDA MedWatch Safety Alert

Xoft Axxent Flexishield Mini product, Model 5300, may shed particles of tungsten. After use during Intraoperative Radiation Therapy (IORT) for in breast tissue, these particles can be mistaken for suspicious calcifications during follow up X-rays or scans.

Additional Information:

FDA MedWatch Safety Alert. Axxent FlexiShield Mini by iCAD (formerly Xoft Inc.): Recall. April 13, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm251353.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun