por Loren Bonner
, DOTmed News Online Editor | July 11, 2013
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.