Elekta, Inc. recalls Elekta Precise Treatment Table

Recall date

January 29, 2015

Source

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

Recall number

Z-1238-2015

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

Worldwide Distribution - USA (nationwide) Distribution and to the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Ecuador, E…

Why it was recalled

It is possible to position the Treatment Table with errors greater than 5mm and no inhibits are displayed, if the positional sensors are not correctly installed during corrective maintenance. Clinical mistreatment may occur if a position error is not detected.

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

What was recalled

Elekta Precise Treatment Table