This correction applies to all GE Healthcare MRI systems with superconducting magnets: 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, Optima MR450w GEM, Discovery MR750W GEM, Optima MR450w. Product Usage: Magnetic resonance (MR) diagnostic devices are intended for producing images of the internal structures of the body based on the spatial distribution of molecules exhibiting magnetic resonance. Most MR systems are intended for diagnostic use.

At certain sites, the MRU may not be connected to the magnet. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. The MRU must be connected to the magnet at all times.

GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref# 60876 dated January 6, 2015 to affected consignees. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction & Contact Information. Customers were instructed to do the following: As a preventative measure, confirm that MRU is connected to the magnet by performing the following four step test on the MRU. 1. Verify the green CHARGER POWER LED is lit. 2. Depress and hold the TEST BATTERY switch for 15 seconds. The green BATTERY TEST LED should light and remain lit while the TEST BATTERY switch is depressed. 3. Place the TEST HEATER toggle switch in the A position. The green HEATER TEST LED should light. If it does not light, depress TEST HEATER LED switch to verify that the LED is functioning. 4. Place the TEST HEATER toggle switch in the B position. Green HEATER TEST LED should light. If it does not light, depress TEST HEATER LED switch to verify that the LED is functioning. If the MRU test does not perform as described in each of the 4 steps above, GEHC strongly recommends that you stop using the system, and immediately call your GEHC representative. Customers with questions may contact their local service representative. For questions regarding this recall call 1-800-437-1171.