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Brilliance CT Systems and Ingenuity CT System (2014-04-01)
- Starting date:
- April 1, 2014
- Posting date:
- April 15, 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-39103
Recalled products
- Brilliance 40/64 Slice CT System
- Brilliance CT Big Bore System - Main Unit
- Brilliance 64 Slice CT System - Main Unit
- Brilliance ICT System - System
- Brilliance 6/10/16 Slice CT System
- Brilliance CT System (16P)
- Brilliance ICT SP System - Main Unit
- Ingenuity CT System
Reason
Philips has become aware that if the service latch is not properly secured during servicing of the device, the table top's subframe becomes free floating causing unintended, horizontal motion. To date, there have been no reported injuries or deaths resulting from this issue.
Affected products
A. Brilliance 40/64 Slice CT System
Lot or serial number
- 9164
- 9186
- 9200
- 9203
- 9207
Model or catalog number
- 4550 110 04011
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES
B. 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
C. 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
D. Brilliance ICT System - System
Lot or serial number
- 100046
- 100101
- 100195
- 100206
- 100223
- 100249
- 100290
- 100440
Model or catalog number
- 728306
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES
E. Brilliance 6/10/16 Slice CT System
Lot or serial number
- 4010
- 5074
- 5092
- 5141
- 5151
- 5158
- 6352
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
F. Brilliance CT System (16P)
Lot or serial number
- 6024
- 6072
- 6103
- 6149
- 6150
Model or catalog number
- 453567005721
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES
G. Brilliance ICT SP System - Main Unit
Lot or serial number
- 200071
Model or catalog number
- 728311
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES
H. Ingenuity CT System
Lot or serial number
- 320123
- 320148
Model or catalog number
- 728323
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Cleveland
44143
Ohio
UNITED STATES