This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Intellispace Portals - DX and HX (2014-03-11)
- Starting date:
- March 11, 2014
- Posting date:
- April 4, 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-38801
Recalled Products
A. Intellispace Portal DX
B. Intellispace Portal HX
Reason
During Spect reconstructions using attenuation correction and scatter correction, no scatter correction is being applied in the Autospect Pro application on Intellispace portal with software version 5 and 6. Resolution recovery is not applied correctly in Spect reconstructions using Astonish in Autospect Pro on Intellispace portal unless the data is acquired with VXGP collimators.
Affected products
A. Intellispace Portal DX
Lot or serial number
87004
950071
950084
Model or catalog number
4598 001 31131
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland) Inc.
3860 NORTH FIRST STREET,
SAN JOSE, CALIFORNIA
95134
UNITED STATES
B. Intellispace Portal HX
Lot or serial number
850001
85104
85359
Model or catalog number
4598 001 30491
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland) Inc.
3860 NORTH FIRST STREET,
SAN JOSE, CALIFORNIA
95134
UNITED STATES