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Last week's GE MRI recall

by Philip F. Jacobus, CEO | February 25, 2015
A number of people called me or wrote to me this week about the GE MRI recall. I really think it is a tempest in a teapot.

First of all, it is important to know that GE Healthcare immediately took action. Just like they did a few years ago with the nuclear camera issue,
GE acted swiftly and took the issue head on.

There is a simple way to diagnose whether there is a problem or not and it only takes a few minutes.

All this came about because two fellows in India took a piece of metal into the MRI suite...duh...and the metal was attracted to the magnet.

Anybody that works around magnets know better than to carry metal into the MRI scan room.

Bottom line, I do not think this is going to have any impact on GE's MRI sales, but I am sure it will have an impact on the two fellows that walked into the MRI suite with an oxygen tank!

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About Phil Jacobus

Phil Jacobus has been involved in health care since 1977, when he visited China to sell equipment. He has done business in 35 countries and still travels extensively. Phil is active in charity, helps rural clinics and always tries to help DOTmed users when he can.

Phil is a member of AHRA, HFMA, AAMI and the Cryogenic Society of America. He has contributed to a number of magazines and journals and has addressed trade groups.

Phil's proudest achievement is that he has been happily married to his wife Barbara since 1989, who helped him found DOTmed in 1998.

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Steven Ford

GE MRI recall

March 04, 2015 08:54

The problem is a serious one and a design problem. The FDA requires that a single fault in a medical device may not lead to a hazardous condition to the patient, the operator, or the public. Additionally, if there are two simultaneous faults that can lead to a hazardous condition but one of those faults can exist undetected, that counts as a single fault, as far as the design safety analysis.

Every day there are people somewhere who bring metal near an MRI magnet. When that happens, the safety equipment has to work. The mistake of GE is that they designed the system so that the quench button could be disconnected and this is undetected. They will need to redesign and modify the MRIs so that they will work like Siemens and other manufacturers do--the machine will not run, or will prominently display an error, if the quench button is not hooked up.

I was in India recently and asked a local engineer about this. He said it was very common not to hook up the quench button. I've seen it on more than one site in the USA, too.

Of course, people are dumb if they bring metal into the magnet. But there are plenty of dumb drivers out there,
and we expect the seat belts to work when we need them.

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