Health product recall

Panorama HFO

Last updated

Summary

Product
Panorama HFO
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Panorama HFO All lots. PANORAMA HFO

Issue

Philips has been informed of an event in which the structural integrity of the Panorama 1.0T HFO system components failed due to unintended excessive pressure buildup of helium gas during a magnet quench. During a quench, a large amount of helium evaporates and is vented outside the building through a venting system. If an unknown blockage is present in the venting system and the pressure exceeds design limits, the structural integrity of the system may be compromised. The magnet may experience an unsolicited quench during normal use or will quench when initiated in an emergency situation by the operator pressing the magnet emergency stop button. 

Philips has received one (1) complaint of system and property damage after quenching the magnet on Panorama 1.0T systems as of November 2023. There was no report of injury or serious harm. 

Philips received a complaint on October 3rd, 2023 regarding a quench that occurred on a Panorama 1.0T system on October 2nd, 2023. The system was about to be decommissioned. It was decided that the magnet would be quenched to remove the magnetic field as part of decommissioning. The quench was triggered via the emergency magnet off/ERDU (emergency run down unit) button. After the button was pressed, involved persons went outside the building to observe the helium vent exit for a plume coming out. Upon return to the exam room the system and its environment was found to have sustained damage.

Recall Start Date: October 3, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Philips Medical Systems Nederland B.V.

Veenpluis 6, Best, Netherlands, 5684 PC

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-74657