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MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).

FDA Recall #Z-0467-2016 — Class II — December 7, 2015

Recall #Z-0467-2016 Date: December 7, 2015 Classification: Class II Status: Terminated

Product Description

MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).

Reason for Recall

Possible installation error of the quench lines of superconducting magnets, used to vent helium gas in the rare event of a quench. Any restriction, obstruction, or improper installation of the quench line may cause the helium gas to be blown directly into the magnet room or other areas. This could lead to displacement of oxygen, cause cold burns, and/or pose a risk to users, patient or others.

Recalling Firm

Siemens Medical Solutions USA, Inc — Malvern, PA

Classification

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

Product Type

Devices

Product Quantity

in US 3752 units

Distribution

Nationwide including : DC, PR, Virgin Islands and Bermuda

Code Information

all units distributed since 1991

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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