FDA Device recall Z-0983-2022
GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery…
- FDA Device
- Class II
- ongoing
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery… by Ge Healthcare, citing during the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0983-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-04 |
| Published | 2022-04-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Explorer, 1.5T SIGNA MR355, 1.5T SIGNA MR360, 1.49T SIGNA MR380, SIGNA Voyager, SIGNA Voyager Premier Edition, SIGNA Artist, Optima MR450w 1.5T, Optima MR450w GEM, Discovery MR450 1.5T, GE 1.5T and 3.0T SIGNA HDx, GE 1.5T and 3.0T SIGNA HDxt, 1.5T and 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA Vibrant, SIGNA 1.5T TwinSpeed, SIGNA Infinity Excite, SIGNA Infinity with Excite Technology, SIGNA OpenSpeed, SIGNA HFO, SIGNA HFO/I MR System, GE 0.7T SIGNA OpenSpeed, SIGNA OpenSpeed with Excite, SIGNA HDe, Brivo MR355, Optima MR360, SIGNA 3.0T MR System, SIGNA Excite 3T, 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD, SIGNA Contour, SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, HighSpeed Plus, MR Vectra, MR MAX, Optima MR430s, Optima MR430s 1.5T, Optima MR430s MRI Scanner, 1.0T MSK Extreme, SIGNA Profile EXCITE, SIGNA Ovation, 0.35T SIGNA Ovation with Excite, SIGNA Prime.
Reason
During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, leading to potential injury.
Identifiers
| code_info | All GE Healthcare MR Systems. UDIs: 01008148480204781120092321QED3257; 01008148480204851119053021QED2493; 01008848380…All GE Healthcare MR Systems. UDIs: 01008148480204781120092321QED3257; 01008148480204851119053021QED2493; 010088483808097321301223488; 010088483808097321301408170; (01)00846082115971(11)160923921)PG45; 01008148480200031117031321QED1184; 01008148480200031117052221QED1241; 01008148480200031117061221QED1268; 01008148480200031117082921QED1348; 01008148480200031118061521QED1775; 01008148480200031118072621QED1888; 01008148480200031118110721QED2090; 010081484802000311120010221QED2892; 010081484802000311120090121QED3227; 01008148480208071921QED1881; 01008148480202491118091321QED1990; 01008148480202491118110121QED2080; 01008148480202491119021421QED2282; 01008148480202491119022121QED2296; 01008148480202491119061321QED2525; 01008148480202491119062821QED2548; 01008148480202491119080121QED2598; 01008148480202491119082921QED; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 0100814848020249111; 010081 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0983-2022%22
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