Several GE Imaging Systems Recalled Following Patient Death

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General Electric (GE) Healthcare has instigated a class 1 recall of several GE Healthcare’s nuclear medicine systems following a report in June of a mechanical difficulty that resulted in the death of a patient. The recall has also been initiated and supervised by the Food and Drug Administration (FDA).

“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," said communications manager for GE Healthcare, Michael Tetuan. 

An investigation into the incident was launched by GE Healthcare and discovered that a portion of the imaging system dislodged and fell onto a patient during the scan.Hawkeye4 unit

The identity of the patient is yet to be revealed, as it would violate certain privacy laws, however, it has been reported that the victim who suffered when part of an Infinia Hawkeye 4 Nuclear Medicine System fell during a scan, was 66 years old. 

Following the investigation, the company concluded that “bolts securing the camera to the gantry were loose, thereby stressing the support mechanism and resulting in the incident.”

As a response to the tragic mishap, GE sent out two letters to hospitals. The first, sent out on June 17, "identified the affected product, recommended that qualified service personnel maintain the equipment and that Preventative Maintenance procedures were executed according to labeling," in addition to asking that the Safety Chapter Sections be re-reviewed with hospital personnel, according to the FDA’s recall notice report.

The second letter, which was sent out on July 3, notified centers of the recall plan of several different nuclear medicine systems and not just the system responsible for the death of a patient, but "because of the similarities in the design of support mechanisms across many products."

The recalled systems are as follows:

•    Infinia Nuclear Medicine Systems

•    VG and VG Hawkeye Nuclear Medicine Systems

•    Helix Nuclear Medicine Systems

•    Brivo NM615

•    Discovery NM630

•    Optima NM/CT640

•    Discovery NM/CT670

Additionally, on June 17, 2013, GE Healthcare sent an Urgent Medical Device Correction Letter to all affected customers.

"Maintaining a high level of safety and quality is our highest priority. 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,” said Tetuan.

“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 added.

A spokesperson of the company said that the global examinations are almost complete; and that “those systems that require repair will be returned to service shortly."

The FDA has stated that any inquiries or quality issues regarding the systems can be directed to a GE Healthcare Services Representative at 1-800-437-1171. Or through the FDA’s MedWatch safety information and adverse event reporting program.

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