Death prompts GE to recall imaging systems

GE Healthcare is recalling systems used in nuclear medicine imaging procedures after a patient died from injuries that occurred while being scanned. The recalled products are designed to enhance images for cardiology, neurology, oncology and other clinical applications.

In a letter dated July 3, GE Healthcare notified hospitals of the voluntary recall of seven systems and devices after its investigation into the death of a patient at a VA medical center. The patient had died from injuries after part of an Infinia Hawkeye 4 Nuclear Medicine System fell during the scan. The company determined that bolts that secured the camera to the gantry were loose.

The systems and devices under recall use a support mechanism design similar to the Infinia Hawkeye 4. The products are:

• Infinia Nuclear Medicine Systems;
• VG and VG Hawkeye Nuclear Medicine Systems;
• Helix Nuclear Medicine Systems;
• Brivo NM615;
• Discovery NM630;
• Optima NM/CT640; and
• Discovery NM/CT670.

Hospitals should stop using the nuclear medicine systems until a GE Healthcare engineer completes an inspection of the system. Facilities will not have to pay for any necessary repairs. GE Healthcare said that a representative will contact hospitals to arrange for the inspection.