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Safety alert on GE Healthcare nuclear medicine systems

 

Hong Kong (HKSAR) – The Department of Health (DH) today (July 6) drew public attention to a safety alert concerning nuclear medicine systems manufactured by GE Healthcare.

The above alert was noticed during DH’s routine surveillance on medical devices safety issues. The affected systems include 1) Infinia nuclear medicine systems; 2) VG and VG Hawkeye nuclear medicine systems; 3) Helix nuclear medicine systems; 4) Brivo NM615; 5) Discovery NM630; 6) Optima NM/CT640 and 7) Discovery NM/CT670.

According to GE Healthcare, a patient in the United States has died due to injuries sustained while being scanned on an Infinia Hawkeye 4, as a portion of the system has fallen onto the patient during the scan.

Investigation by the manufacturer revealed that the bolts which secured the camera to the gantry were loose, thereby stressing the support mechanism of the device and resulting in the incident.

Because of the similarities in the design of support mechanisms across many products, GE Healthcare advised healthcare facilities to cease the use of all the above-mentioned systems in addition to the Infinia system which was involved in the incident, until they have inspected all affected systems to verify that the support mechanism fasteners are secured properly.

According to the local supplier, GE Medical Systems Hong Kong Limited, 14 units of the affected nuclear medicine systems were installed at public and private hospitals in Hong Kong. The supplier has informed all affected users and will arrange inspection of the systems as soon as possible.

“So far, the DH has not received any relevant report of adverse incidents related to the devices in Hong Kong,” a DH’s spokesman added.

The DH has informed public and private hospitals and relevant medical associations about the alert and shall continue to liaise with the supplier on the follow-up actions.


Source: HKSAR Government

Published on: 2013-07-06

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