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CT TAVI Planning Application in Intellispace Portal V.6 (2014-11-09)
- Starting date:
- November 9, 2014
- Posting date:
- November 26, 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-42581
CT TAVI Planning Application in Intellispace Portal V.6
Reason
CT Transcatheter Aortic Valve Implantation (CT TAVI) planning application, supplied as an option to Intellispace Portal Software Version 6, may display incorrect measurements of cardiac and aortic anatomy. Clinicians use this information to plan TAVI procedures and to select and size the Transcatheter Heart Valve (THV) to be used in the procedures. Reliance on incorrect information could contribute to an unsuccessful THV implantation procedure.
Affected products
CT TAVI Planning Application in Intellispace Portal V.6
Lot or serial number
550012
Model or catalog number
4598 003 56951
Companies
- Manufacturer
-
Philips Medical Systems Nederland B.V
Veenpluis 4-6,
Best
5684PC
NETHERLANDS