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 |
|
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.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
Contact Information |
1800 251 400 - Philips Customer Care Centre |