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Siemens Medical Solutions USA, Inc recalls MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
Recalled December 30, 2015 · FDA recall Z-0467-2016 · Siemens Medical Solutions USA
Hazard
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. · FDA Class II
Units
in US 3752 units
Sold at
Nationwide including : DC, PR, Virgin Islands and Bermuda
Description
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.
Product
MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →