Skip to content
Recall Observatory FDA recall evidence

Device product

MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).

Z-0467-2016

December 07, 2015

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 72861
Status
Terminated
Classification
Class II
Quantity
in US 3752 units
Official record key
device-enforcement:Z-0467-2016

Official wording

Reason: 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.

Code information: all units distributed since 1991

Distribution pattern: Nationwide including : DC, PR, Virgin Islands and Bermuda

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.