Medical device recalls Moderate risk

Philips Electronics North America Corporation recalls Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.

Recall date
November 3, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0764-2016
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

Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.

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