GE Healthcare has initiated a class 1 recall of several of their nuclear medicine imaging systems because of a mechanical problem that could cause serious injury or death, the US Food and Drug Administration (FDA) reminded health providers July 29.
On June 5, 2013, “GE Healthcare became aware of an incident at the James J. Peters VA Medical Center in the Bronx, New York, in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4,” Michael Tetuan, communications manager for GE Healthcare, toldMedscape Medical News.
An investigation into the incident by GE Healthcare found that a portion of the system fell onto the patient during the scan. The company determined that bolts securing the camera to the gantry were loose, thereby stressing the support mechanism and resulting in the incident.
The company says because of similarities in the design of support mechanisms across many imaging systems, they are recalling the following systems:
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Infinia Nuclear Medicine Systems
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VG and VG Hawkeye Nuclear Medicine Systems
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Helix Nuclear Medicine Systems
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Brivo NM615
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Discovery NM630
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Optima NM/CT640
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Discovery NM/CT670
The recall, which is actually an on-site inspection and repair if necessary, includes all types and manufacturing dates for these products.
On June 17, 2013, GE Healthcare sent an Urgent Medical Device Correction Letter to all affected customers.
The company followed up on July 3 with an urgent medical device recall letter to customers.
“Maintaining a high level of safety and quality is our highest priority,” Tetuan said. “Based on current investigation information, GE Healthcare recommends that all sites cease use of their affected Nuclear Medicine system until GE Healthcare can complete an inspection of their individual equipment.”
GE Healthcare will inspect all systems to verify that the support mechanism fasteners are secured properly. If an issue with the support mechanism fasteners is found on the system, a GE Healthcare engineer will coordinate the replacement of affected parts and ensure that the system is operating safely and meets all specifications, he said.
Tetuan said he is “unable to give a global number of units affected at this time…[but] as of this moment, we are nearly complete with our inspections globally. Those that require repair will be returned to service shortly.”
Customers with questions regarding this recall can contact a GE Healthcare Services Representative at 1-800-437-1171.
To report problems with these products, contact MedWatch, the FDA’s safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online athttps://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available athttp://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.