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Intera 1.5T MRI System-Main Unit(2014-05-08)
- Starting date:
- May 8, 2014
- Posting date:
- June 5, 2014
- 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-39815
Recalled Products
Intera 1.5T MRI System-Main Unit
Reason
Philips has become aware that the cross reference lines of transversal images from spinal scans are displayed in an incorrect position on a fused image which has been generated through mobiview post processing. The cross reference lines are correctly displayed on the unfused stations. The problem can occur when the field of view of the clinical scan stations is below (more towards the feet) the light visor position. In such situation an error is made in calculating the position information. This causes incorrect positioning of cross-reference lines on fused sagittal images.
Affected products
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