Siemens Medical Solutions USA, Inc recalls MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).

Recall date

December 7, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0467-2016

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Nationwide including : DC, PR, Virgin Islands and Bermuda

Why it was recalled

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.

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

What was recalled

MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).