FDA Device recall Z-1035-2015
This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa H…
- FDA Device
- Class I
- terminated
- Published 2015-02-25
On 2015-02-25 the FDA classified a Class I recall of This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa H… by Ge Healthcare, citing 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 resu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1035-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-01-07 |
| Published | 2015-02-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | Mfg Lot or Serial # System ID 00000678440YM9 11 00000439289YM0 8 00000440422YM4 12 00000159739MR2 10 00000340776HM…Mfg Lot or Serial # System ID 00000678440YM9 11 00000439289YM0 8 00000440422YM4 12 00000159739MR2 10 00000340776HM4 MRR9350 00000300911HM5 MRR8614XXX 00000307145MR3 MR307145MR3XXX 00000347253HM7 MRR9546XXX 00000014401YR4 2867718MRHDEXXX 00000227450MR7 333MR3TXXX 00000286146MR6 813EXCITEHDXXX 00000005670GQ5 33575MRI 00000015190GQ2 813EXCITEHD 000000000R5168 PPR88300 00000263679HM3 MEX68913 104203 GPX23300 00000117703YM9 MP917500 00000275290MR5 M2322231 00000144994MR1 F4168003 00000142868MR9 M9886807 00000208223MR8 M4488929 00000834BD4B76 M2865810 00000015769GQ3 M200598201 00000287360MR2 IL1028MR04 00000269936MR1 110010MR03 00000010081GQ8 M4497252 00000265724MR5 80040MRS02 00000213821MR2 00568MRS02 00000274388MR8 M4160077 00000439293YM2 850270280 00000439303YM9 850270057 00000439318YM7 850270174 00000439320YM3 850270022 00000439325YM2 850270186 00000279611MR8 10079MRM74 00000000905M20 PL2130MR01 00000165934MR1 850270060 000000000R6047 55MR2726459 00 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1035-2015%22
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