Elekta Limited recalls Elekta Unity

Recall date

January 4, 2019

Source

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

Recall number

Z-0706-2019

FDA classification

Class II

Brand / firm

Elekta Limited

Sold / distributed

TX and WI, Germany, Denmark, Netherlands, United Kingdom

Why it was recalled

In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the speakers can become dislodged and be pulled into the bore.

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 Unity