SIGNA Excite 3T. Magnetic Resonance Imaging System
Check against the official notice below — it lists the full affected range.
GE Healthcare, LLC is recalling 55 units of the SIGNA Excite 3T Magnetic Resonance Imaging System due to a potential hazard where images may be flipped left to right. The affected systems have been distributed worldwide, including throughout the United States and in numerous countries across Europe, Asia, the Middle East, Africa, and the Americas.
The recall record does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
There is potential for the images to be flipped left to right.
Reason for recall: There is potential for the images to be flipped left to right. Distribution: Worldwide Distribution. US nationwide, Argentina, Australia, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, China, Denmark, Ecuador, Ethiopia, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Italy, Japan, Korea, Kuwait, Lebanon, Mexico, Netherlands, New Zealand, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syr Quantity: 55 units Lot/code info: System IDs: 3422, 209577MRMOBX, 407303CHMR, SIMONVILLAGES3T, 321MR3T3, 321MR3T2, 407999MR3T, 316268TWIN3, 8109873T, 732473MR, 702433SIM3T, 864573MBMR2, 901726OPMR, 214879INVIVO, 817578LGMR2, 972665XDDAMR1 2284SIG15T, 47413, 2550000, 975, 604270MR3T, 416813MR3, 416369MR2, 082427130025 082427130020, 082427130022, 082427270012, 082427270011, 082427150025, 082427020020, 082427010032, 082427160051, 082427160050, 082427120042, 082427120027, 082427030037, 082427250016, 082427070046, 082427150026, 082427090035, 082427140034, 082427140040, 082427090044, 082427100075, 082427120029, 082427070049, 082427070048, 082427220010, 082427300008, YM1408, YM1414, YM1406, 850270152, LB1049MR02, PK1184MR01
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.