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INTELLISPACE PORTAL (2016-03-09)
- Starting date:
- March 9, 2016
- Posting date:
- March 29, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-57684
Affected products
A. INTELLISPACE PORTAL
Reason
The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90° or 180°. Relative to one another. However, certain Gamma cameras, e.g., the Marconi Axis and Irix cameras, allow for other relative detector angles. Philips has become aware that data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro, and the results will likely be erroneous.
Affected products
A. INTELLISPACE PORTAL
Lot or serial number
All lots
Model or catalog number
881001
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best
5684
NETHERLANDS