Achieva and Intera 1.5T MRI System - Main Unit (2018-03-22)
- Starting date:
- March 22, 2018
- Posting date:
- April 13, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-66402
Affected products
Reason
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.
Affected products
Achieva 1.5T MRI System- Main Unit
Lot or serial number
All lots.
Model or catalog number
ACHIEVA 1.5T
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS
Intera 1.5T MRI System-Main Unit
Lot or serial number
All lots.
Model or catalog number
INTERA 1.5T
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684 PC
NETHERLANDS