Elekta, Inc. recalls Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as d…

Recall date

January 7, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1088-2015

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

Worldwide Distribution - USA including AZ, CA, FL, KS, LA, MN, MO, NY, NC and Internationally to Austria, Bulgaria, Canada, China, Germany, Hungary, Italy, Malaysia, Malta, Netherlands, Norway, Russia, Spain, Sweden, Taiwan and Ukraine.

Why it was recalled

Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.