Medical device recalls Moderate risk

Philips Medical Systems (Cleveland) Inc recalls Brilliance iCT Computed Tomography X-ray system

Recall date
April 13, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1695-2015
FDA classification
Class II
Brand / firm
Philips Medical Systems (Cleveland) Inc
Sold / distributed
Internationally to the countries of China and Norway.

Why it was recalled

A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners.

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

What was recalled

Brilliance iCT Computed Tomography X-ray system

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