FDA-Device2015-12-30Class II
MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
Siemens Medical Solutions USA, Inc
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.
Sold states
Nationwide including : DC, PR, Virgin Islands and Bermuda
Affected count
in US 3752 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0467-2016Don't want to check this manually?
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