Elekta, Inc. recalls Medical Linear Accelerator

Recall date

July 8, 2016

Source

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

Recall number

Z-2721-2016

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

AL, AZ, CA, FL, GA, KY, MI, MN, MO, NE, NJ, NY, NC, OH, OK, PA, SC, TX, WA, WV, Argentina, Austria, Australia, Bosnia and Herzegovinia, Bangladesh, Belgium, Bulgaria, Brazil, China, Columbia, Cuba, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, Indonesia, Ireland, Isra…

Why it was recalled

There have been instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.

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

What was recalled

Medical Linear Accelerator