Canon Medical Systems Korea is voluntarily recalling all Vantage Galan 3T MODEL MRT-3020 MRI units installed in Korea after one of the devices in use in Japan caught fire during operations.

According to the Ministry of Food and Drug Safety, the incident happened at a hospital in Japan when an operator heard an unusual sound and entered the scan room.

When the hospital staff entered the scan room, the staff smelled smoke and evacuated the patient, the ministry said.

"After seeing a fire inside the system through a gap in the system cover, the operator pressed the emergency run down switch to cut power to the magnet of the MRI, extinguished the fire, and called the fire department," the MFDS said in a report. "The incident did not result in fire spread or loss of life."

However, the MFDS did not provide any information about which hospital the incident had happened.

"Canon's MRI medical devices are being recalled from July 17 to Aug. 16, following a decision by its headquarters," the MFDS said. "The method of recall is for the company's engineers to visit hospitals to check the equipment."

The ministry stressed that 11 of the 14 devices currently installed in Korea have been checked, while two devices cannot be recalled due to the closure of medical institutions, and one is scheduled for inspection within the deadline.

"To date, there have been no reports of fire or human casualties due to the use of these medical devices, but since the possibility of a fire occurring in the future cannot be ruled out, MFDS is requesting and monitoring the prompt repair of all products within the recall period," an MFDS official told Korea Biomedical Review. "In addition, an investigation is currently underway at headquarters to determine the cause of the incident."

The MFDS official stressed that it would continue to monitor the investigation results and trends of overseas regulatory agencies and take appropriate safety measures, such as changing precautions for use or ordering a suspension of use, if necessary.

Regarding the incident, a Canon Medical Systems Korea official confirmed that the recall process was underway.

"We expect to complete the recall process by this week and submit a report to the MFDS," the official said. "It is believed that the fire occurred due to the wear and tear in the cable route."

Canon headquarters is immediately conducting an internal investigation into the cause of the wear and tear, and the Korean offshoot will continue to request confirmation from headquarters, she added.