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Brilliance CT Big Bore Systems and Gemini TF System
- Starting date:
- October 24, 2012
- Posting date:
- November 26, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-15879
Recalled Products
- Brilliance CT Big Bore System - Main Unit
- Brilliance CT Big Bore System - Extended Brilliance Workspace
- Gemini TF 64 PET/CT System Main Unit
Reason
The Tumorloc application has the capability to generate intensity projection datasets from respiratory gated data. Philips healthcare has become aware of a circumstance where these generated datasets are flipped and incorrectly labeled left to right when they are saved to disk.
Affected products
A. Brilliance CT Big Bore System - Main Unit
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
4535 670 88051
Companies
- Manufacturer
- Philips Medical Systems (Cleveland) Inc.
B. Brilliance CT Big Bore System - Extended Brilliance Workspace
Lot or serial number
11365, 11704, 9127
Model or catalog number
4550 110 02031
Companies
- Manufacturer
- Philips Medical Systems (Cleveland) Inc.
C. Gemini TF 64 PET/CT System Main Unit
Lot or serial number
7103
Model or catalog number
4598 001 18551
Companies
- Manufacturer
- Philips Medical Systems (Cleveland) Inc.