GE Healthcare, LLC recalls GE Healthcare MR superconducting magnets, a component of GE
Recalled Product
GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.5T SIGNA HDxt MR System, GE 3.0T SIGNA HDxt MR System, 1.5T SIGNA HDxt, 3.0T SIGNA HDxt, 1.5T SIGNA HDxt Mobile, 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA Vibrant systems, nuclear magnetic resonance imaging systems.
Hazard / Issue
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Issued by
FDA
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