Brilliance CT Big Bore System-Main Unit, Brilliance ICT System - System, Brilliance ICT SP System - Main and Ingenuity CT System (2018-02-14)
- Starting date:
- February 14, 2018
- Posting date:
- March 13, 2018
- 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-66128
Affected products
- BRILLIANCE CT BIG BORE SYSTEM-MAIN UNIT
- BRILLIANCE ICT SYSTEM- SYSTEM
- BRILLIANCE ICT SP SYSTEM - MAIN
- INGENUITY CT SYSTEM
Reason
Upon closing the Emergency Stop (E-STOP) the system performs an internal check. As a result of the motion controller in the couch, there is a delay in the response to the internal check. This delay may cause the couch carbon top to enter a free float state, which may allow it to move during patient load or unload activities. This free float motion results in the ESTOP being opened due to the unexpected couch motion. This issue occurs frequently after closing E-STOP. The motion controller in the couch detects a power problem and disables the horizontal motor, which allows the couch top to free-float*.
*The term free float refers to the couch top being in a state that is not locked in position by the brake or being moved in a controlled fashion manual or automatic motion.
Affected products
A. BRILLIANCE CT BIG BORE SYSTEM-MAIN UNIT
Lot or serial number
Not applicable
Model or catalog number
4535 670 88051
728244
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland) Inc.
595 Miner Road
Cleveland
44143
UNITED STATES
B. BRILLIANCE ICT SYSTEM- SYSTEM
Lot or serial number
Not applicable
Model or catalog number
728306
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland) Inc.
595 Miner Road
Cleveland
44143
UNITED STATES
C. BRILLIANCE ICT SP SYSTEM - MAIN
Lot or serial number
Not applicable
Model or catalog number
728311
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland) Inc.
595 Miner Road
Cleveland
44143
UNITED STATES
D. INGENUITY CT SYSTEM
Lot or serial number
Not applicable
Model or catalog number
728323
728326
Companies
- Manufacturer
-
Philips Medical Systems (Cleveland) Inc.
595 Miner Road
Cleveland
44143
UNITED STATES