Reported Apr 27, 2022 · Ongoing
GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- 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.
- Lot codes and dates
- All GE Healthcare MR Systems
- UDIs
01008148480204781120092321QED325701008148480204851119053021QED2493010088483808097321301223488010088483808097321301408170(01)00846082115971(11)160923921)PG4501008148480200031117031321QED118401008148480200031117052221QED124101008148480200031117061221QED126801008148480200031117082921QED134801008148480200031118061521QED177501008148480200031118072621QED188801008148480200031118110721QED2090010081484802000311120010221QED2892010081484802000311120090121QED322701008148480208071921QED188101008148480202491118091321QED199001008148480202491118110121QED208001008148480202491119021421QED228201008148480202491119022121QED229601008148480202491119061321QED252501008148480202491119062821QED254801008148480202491119080121QED259801008148480202491119082921QED010081484802024911101008148480202491110100814848020249111010081484802024911101008148480202491110100814848020249111010081484802024911101008148480202491110100814848020249111
- US System ID numbers
2,799 of 2,799 codes
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
- Amount recalled
- 18,411 systems
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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