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.