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Type of Product Medical Device
TGA Recall Reference RC-2021-RN-01646-1
Product Name/Description Philips Ingenia 1.5T, Ingenia 1.5T Evolution, Ingenia 3.0T, Ingenia Elition X Magnetic Resonance System

Multiple system codes, serial numbers and device identifiers

ARTG 230064
(Philips Electronics Australia Ltd - MRI system, full-body, superconducting magnet)
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 30/07/2021
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue Philips has detected an issue with a pressure relief valve in the magnet assembly where a 42psi pressure relief valve was installed, instead of a 3.75 psi valve. The relief valve is used for controlling the pressure of helium when the magnet is not attached to a working cryo-system and is off-cooling. All MR systems in the scope of this notification have a secondary pressure relief valve at 5 psi which alleviates high pressure release of helium gas, releasing instead a moderate amount of helium gas.

If this issue does occur, it may lead to the following harms:
If a patient, operator or service engineer is adjacent to the system during off-cooling skin burns or cold burns of eyes may occur.
If the moderate release of helium depletes the oxygen in the room and the exposure is for an extended period of time, a patient, operator or service engineer may experience asphyxia.

To date, Philips have received no customer complaints related to this issue.
Recall Action Product Defect Correction
Recall Action Instructions Philip is advising customers that devices will be inspected to confirm if the non-conforming pressure relief (42 psi) has been installed. If the system has a 42 psi valve, a replacement valve with the correct 3.75 psi valve will be installed.
Contact Information 1800 251 400 - Philips Customer Care Centre