| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00347-1 |
| Product Name/Description |
Philips Intera 0.5T/1.0T/ 1.5T, Achieva 1.5T, Multiva 1.5T and Ingenia CX 1.5T
ARTG Number: 230064
(Philips Electronics Australia - MRI system, full-body, superconducting magnet) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
23/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
In rare cases, helium gas may escape into the examination room when superconductivity is lost (also known as quenching of the magnet) and at the same time the designed helium ventilation path is impeded. Philips has become aware of one instance where this happened in a Philips system. Investigation found the metal burst disk assembly in the vent path did not perform according to specifications. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
As an interim measure Philips is referring users to follow the relevant sections of the current IFU in the event helium gas escapes into the examination room during a magnet quench; and
As a long term correction Philips will schedule an inspection of all MRI systems that may be affected by this issue and where applicable the spare 3” metal burst disk will be replaced during this inspection. Philips advises that planning will be carefully coordinated and where possible this correction will be done during off hours to reduce any disturbance to customers.
This action has been closed out on 11/07/2019 |
| Contact Information |
1800 251 400 - Customer Service Support |