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Philips Medical Brilliance, Precedence and Gemini Systems
- Starting date:
- May 14, 2013
- Posting date:
- June 18, 2013
- 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-34233
Recalled products
- Brilliance 40/64 Slice CT System
- Precedence System - 16 Slice
- Precedence System - 6 Slice
- Brilliance CT Big Bore System - Main Unit
- Gemini GXL 6/10/16 Slice PET/CT System - Unit
- Gemini TF 16 PET/CT System - Main Unit
- Gemini TF 64 PET/CT System - Main Unit
- Brilliance 64 Slice CT System - Main Unit
- Brilliance iCT System
- Brilliance 6/10/16 Slice CT System
- Brilliance CT System (16p)
- Gemini System - 2 Slice
- Brilliance iCT SP System - Main
- Gemini TF Big Bore PET/CT Imaging System - Main Unit
Reason
The stated tolerance for CTDI(VOL) in the instructions for use manual did not accurately represent all systems. On some systems the measured CTDI(VOL) value may fall outside of these stated tolerances.
Affected products
A. Brilliance 40/64 Slice CT System
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 4550 110 04011
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES
B. Precedence System - 16 Slice
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 2169-3000A
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES
C. Precedence System - 6 Slice
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 2169-3002A
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES
D. 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.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES
E. Gemini GXL 6/10/16 Slice PET/CT System - Unit
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 4535 679 71891
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES
F. Gemini TF 16 PET/CT System - Main Unit
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 4535 679 83931
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES
G. Gemini TF 64 PET/CT System - Main Unit
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 4535 679 94741
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES
H. Brilliance 64 Slice CT System - Main Unit
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 4550 110 00921
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES
I. Brilliance iCT System
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 728306
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES
J. Brilliance 6/10/16 Slice CT System
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 4535 670 73181
- 4535 670 78851
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES
K. Brilliance CT System (16p)
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 453567005721
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES
L. Gemini System - 2 Slice
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 45356 790 0891
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES
M. Brilliance iCT SP System - Main
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 728311
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES
N. Gemini TF Big Bore PET/CT Imaging System - Main Unit
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 4598 001 18561
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES