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Intera 1.5T Power/Pulsar, Model Number 781105. Nuclear Magnetic Resonance Imaging System

FDA Recall #Z-0878-2019 — Class II — December 21, 2018

Recall #Z-0878-2019 Date: December 21, 2018 Classification: Class II Status: Terminated

Product Description

Intera 1.5T Power/Pulsar, Model Number 781105. Nuclear Magnetic Resonance Imaging System

Reason for Recall

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.

Recalling Firm

Philips Medical Systems Nederlands — Best

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

11226 total

Distribution

U.S. Nationwide distribution.

Code Information

All systems

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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