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El incidente incita GE para recordar cámaras fotográficas gammas

por Loren Bonner, DOTmed News Online Editor | July 11, 2013
Infinia Hawkeye 4 SPECT/CT
from GE Healthcare.
GE Healthcare issued a warning to customers about its nuclear medicine imaging systems after a patient at the James J. Peters VA Medical Center in the Bronx, New York, died on June 5 from injuries sustained while being scanned with GE's Infinia Hawkeye 4 SPECT/CT.

GE has also taken the initiative to recall the systems, and the U.S. Food and Drug Administration has posted a notice to inform health care facilities about it.

Benjamin Fox, a spokesperson for GE, told DOTmed News by e-mail that based on the current investigation into the incident, GE is recommending that all facilities with GE Infinia nuclear medicine systems, in addition to Brivo NM615, Discovery NM630, Optima NM/CT640, and Discovery NM/CT670 systems, stop use until an individual inspection by a GE technician takes place.

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"GE Healthcare will inspect all systems to verify that the support mechanism fasteners are secured properly," said Fox.

Apparently, the victim at the Bronx VA Hospital was undergoing a procedure using the Infinia Hawkeye 4 SPECT/CT when the apparatus collapsed and crushed him.

Following the incident, GE sent a safety letter to its customers recommending that qualified service personnel maintain the equipment and the preventative maintenance procedures be adhered to. The decision to recall the systems and have customers stop using them until a GE technician can complete inspection of the individual equipment takes it a step further, however.

"If no issue is found with the support mechanism fasteners, the site can resume use of the device. If an issue with the support mechanism fasteners is found on a system, the GEHC Field Engineer will coordinate the replacement of impacted parts, and ensure that the system is operating appropriately and meets all specifications," said Fox.

He added that all of these activities will be free of charge for facilities.

Ralph Frizzle

Preventative Maintenance Inspection

July 11, 2013 04:26

The question has to be asked: Could this have been prevented if the equipment had a qualified engineer perform the manufactures suggested equipment maintenance and safety inspection schedule?

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Brian Tunell

GE Recall

July 12, 2013 01:44

Unfortunately, this unit was under a service contract with GE. If the failure, which hasn't been detailed, was a normal part of GE's PM, then maybe it could have been prevented. But if this is due to failure of a part or assembly that isn't in the GE PM list, then No, it wouldn't have been preventable.
Since GE has placed a recall on all their related Nuclear Cameras, it's most likely not a routine part or assembly that is checked under their PM schedule.

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Bill Schimmer

Re: GE Recall

July 13, 2013 10:57

I agree. If the failed item was part of the PM procedure, the incident would have been avoidable. But that would lay blame on the service engineers both in house and OEM. They have added an inspection which indicates it is not routinely inspected.
I think GE should disclose the failed component to the customer and indicate a remedy to ensure failure is not an option.
Was the failure the fault of missed PM items, or was there a design flaw or QA inspection during manufacture where an FMI with additional hardware needs to be added.
We need to go overboard with the remedy, not just a feel good inspection.

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Brian Tunell

Re: GE Recall

July 13, 2013 11:05

Unfortunately, the only recent recall for this type of system by GE listed in the FDA database is from April 10th of this year (Recall number Z-1078-2013). Maybe they haven't gotten it listed yet?

See http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116030

This particular recall is a class 2, but I imagine the patient death will result in a class 1.

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