News | April 14, 2011

Axxent FlexiShield Mini Recalled Due to Possible False Positive Breast Exams

April 14, 2011 – A class I recall has been issued for the Xoft Axxent Flexishield Mini because the product may shed particles of tungsten that can be mistaken for suspicious breast calcifications during follow up X-rays or scans.

The device consists of a circular silicone rubber pad containing tungsten particulate. The pad is 12.7 cm in diameter and 0.1 cm (1 mm) thick. It 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 limits the amount of radiation encountered by the skin or healthy tissue by shielding areas that do not need radiation therapy.

The pad should be placed over the surface that needs shielding from the radiation therapy. It can be cut to accommodate the shape of the radiation therapy beam. It can be used on the skin, and it can be used to shield internal tissue from radiation therapy during intraoperative radiation therapy (IORT).

This product was manufactured from Sept. 11, 2009 through June 28, 2010, and distributed nationwide from Oct. 2009 through Dec. 2010.

Xoft conducted an extensive and comprehensive failure investigation and risk assessment regarding this matter. After laboratory testing and a comprehensive literature review, Xoft has concluded that there is no evidence that these tungsten particles are toxic – only a few health effects have been reported in humans with this material, each of which involved exposure at much higher levels. No permanent impairment of bodily functions or permanent damage to body structures is anticipated.

On Feb. 3, 2011, the company sent an Urgent Field Removal Action letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.

Customers were instructed to stop using all units of the Flexishield Mini Catalog Number F5300 in their inventory and return them to the company.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

For more information: (877) 963-8327

Related Content

First Hospitals Achieve Inter-System Connectivity Across Accuray Radiation Therapy Platforms
News | Radiation Therapy | January 19, 2018
Accuray Inc. announced recently that the Heidelberg University Hospital in Heidelberg, Germany, and Oscar Lambret...
RayStation Selected for New Carbon Ion Therapy Center in Japan
News | Treatment Planning | January 18, 2018
January 18, 2018 – RayStation has been chosen as the treatment planning system for a new carbon-ion therapy facility
Raysearch Receives First Order for the Raycare Oncology Information System
News | Oncology Information Management Systems (OIMS) | January 18, 2018
January 18, 2018 – Anderson Regional Cancer Center (ARCC) in Meridian, Mississippi, has placed the first order for...
Transpara Deep Learning Software Matches Experienced Radiologists in Mammogram Reading
News | Computer-Aided Detection Software | January 12, 2018
Deep learning and artificial intelligence improves the efficiency and accuracy of reading mammograms, according to...
Women Prefer Getting Mammograms Every Year
News | Mammography | January 09, 2018
Women prefer to get their mammograms every year, instead of every two years, according to a new study presented at the...
Planmed Clarity 2-D Digital Mammography System Receives FDA Approval
Technology | Mammography | January 08, 2018
The U.S. Food and Drug Administration (FDA) issued an approval letter for the Planmed Clarity 2-D full-field digital...
Overweight Women May Need More Frequent Mammograms
News | Mammography | January 04, 2018
Women with higher body mass index (BMI) face an increased risk of not detecting their breast tumor until it has become...
Mevion Receives 510(k) Clearance for Hyperscan Pencil Beam Scanning Proton Therapy
Technology | Proton Therapy | January 04, 2018
Mevion Medical Systems has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Mevion S250i...
Study Compares Radiosurgery and Whole-Brain Radiation in Lung Cancer Patients With Multiple Brain Metastases
News | Radiation Therapy | January 03, 2018
Although targeted therapies have produced dramatic advances in the ability to control some types of advanced lung...
About 25 percent of screening patients and 60 percent of diagnostic patients do not have prior mammograms available for comparison at the time of their examinations due to the lack of interoperability or other restrictions preventing clinicians from accessing prior exams.

About 25 percent of screening patients and 60 percent of diagnostic patients do not have prior mammograms available for comparison at the time of their examinations due to the lack of interoperability or other restrictions preventing clinicians from accessing prior exams.

Feature | Breast Imaging | January 02, 2018 | Kathryn Pearson Peyton, M.D.
Sixty million women undergo regular screening mammography in the United States, but even in the digital age, it is di
Overlay Init