Philips Electronics North America Corporation recalls Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.

Recall date

November 3, 2015

Source

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

Recall number

Z-0765-2016

FDA classification

Class II

Brand / firm

Philips Electronics North America Corporation

Sold / distributed

Worldwide Distribution. US states of TN and IN and the countries of Australia, Belgium, Egypt, France, Germany, Japan, Republic of Korea, Netherlands, and Saudi Arabia.

Why it was recalled

Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the C-arc. Because of improper adjustment and tolerances, when the C-arc is initially stopped in an unbalanced position, the air gap of the brake can become too large, resulting in continued C-arc movement (C-arc is looking for balanced position).

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

What was recalled

Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.