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Gemini TF (16, 64, and Big Bore) PET/CT Systems - Main Units (2013-12-09)
- Starting date:
- December 9, 2013
- Posting date:
- January 17, 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-37583
Recalled products
- Gemini TF 16 PET/CT System-Main Unit
- Gemini TF 64 PET/CT System-Main Unit
- Gemini TF Big Bore PET/CT Imaging System-Main Unit
Reason
Philips has become aware that the PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complete and will not allow the PET acquisition to begin, resulting in an unexpected incomplete study.
Affected products
A. Gemini TF 16 PET/CT System-Main Unit
Lot or serial number
All lots
Model or catalog number
- 4535 679 83931
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES
B. Gemini TF 64 PET/CT System-Main Unit
Lot or serial number
All lots
Model or catalog number
- 4535 679 94741
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES
C. Gemini TF Big Bore PET/CT Imaging System-Main Unit
Lot or serial number
All lots
Model or catalog number
- 4598 001 18561
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES