Medical device recalls Moderate risk

Philips Medical Systems Nederlands recalls Intera Achieva 1.5T IT Nova, Model Number 781175. Nuclear Magnetic Resonance Imaging System

Recall date
December 21, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0891-2019
FDA classification
Class II
Brand / firm
Philips Medical Systems Nederlands
Sold / distributed
U.S. Nationwide distribution.

Why it was recalled

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

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

What was recalled

Intera Achieva 1.5T IT Nova, Model Number 781175. Nuclear Magnetic Resonance Imaging System

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