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Loose bolts caused the collapse of a GE SPECT/CT scanner on June 5, killing a patient and leading to a recall of GE nuclear medicine systems, according to a letter from GE announcing the recall.

As we reported last month, a 66-year-old patient at the James J. Peters VA Medical Center in the Bronx, New York, died on June 5 after the gamma camera of a GE Infinia Hawkeye 4 scanner collapsed onto him while he was being scanned. The hospital has declined to identify him, citing privacy rules.

GE Healthcare spokesman Benjamin Fox told DOTmed News that GE is recommending that operators stop using GE nuclear medicine systems until a GE technician can inspect them. The recall covers not only Infinia scanners, but also VG, VG Hawkeye, Brivo NM 615, Discovery NM 630, Optima NM/CT 640, and Discovery NM/CT 670 nuclear medicine systems. And it covers Helix nuclear medicine systems, which were manufactured by Elscint. GE bought Elscinct’s nuclear medicine business in 1998.

Fox said in an e-mail:

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

A Food and Drug Administration notice accompanied the letter that GE sent to users of its scanners. The FDA notice said GE was voluntarily recalling the systems.

GE had previously sent a letter to its customers recommending that qualified service personnel maintain the equipment and that standard preventive maintenance procedures be followed. The recall letter ups the ante.

Fox said GE will not charge for inspections and other recall activities. “If no issue is found with the support mechanism fasteners, the site can resume use of the device,” he said. “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.”

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