Vehicle Safety Product Safety Food Safety Pet Safety Drug Safety Device Safety Workplace Safety Bridge Safety Aviation Safety Dam Safety Nursing Homes Water Safety Railroad Safety Pipeline Safety Environmental

Ingenia 3.0T, Model Number 781342. Nuclear Magnetic Resonance Imaging System

FDA Recall #Z-0911-2019 — Class II — December 21, 2018

Recall #Z-0911-2019 Date: December 21, 2018 Classification: Class II Status: Terminated

Product Description

Ingenia 3.0T, Model Number 781342. 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

Back to All Device Recalls