Devices

Software Version: GE Healthcare MRI systems

Model / Serial
This correction applies to some units of the following GE Healthcare MRI system types: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T HD Echospeed, Signa Excite 1.5T HD Highspeed, 1.5T Signa Infinity TwinSpeed , 1.5T Signa Infinity EchoSpeed Plus, 1.5T Signa Infinity HiSpeed Plus, 1.0T Signa Infinity HiSpeed Plus. 1.0T Signa Infinity SmartSpeed, Signa EXCITE 3.0T, Signa EXCITE 3.0T HD, Signa Excite 1.5T TwinSpeed, Signa Excite 1.5T EchoSpeed, Signa Excite 1.5T HiSpeed, Signa Excite 1.5T SmartSpeed, Signa Excite 1.5T, Signa Excite 3.0T, Signa Contour/I, Signa OpenSpeed, Vectra, MR Max, Signa Profile, Signa Ovation, Optima MR450w GEM, Discovery MR750W GEM, Optima MR450w, Signa PET/MR, MR950.
Product Description
MRI System, full-body, superconducting magnet
Manufacturer
GE Healthcare
1 Event
- translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

Manufacturer

GE Healthcare

Manufacturer Parent Company (2017)
General Electric Company
Manufacturers representative
GE Healthcare
Source
SFDA

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