Brilliance iCT Heavyweight Gantry Scanner, M/N 728306, S/N: 100016, 100018 -100025 The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
This recall has been terminated (originally issued September 22, 2010).
- Recall Initiated
- April 14, 2010
- Posted
- September 22, 2010
- Terminated
- September 24, 2012
- Recall Number
- Z-2460-2010
- Quantity
- 9 units
- Firm Location
- Cleveland, OH
- Official Source
- View on FDA website ↗
Reason for Recall
The gantry covers of the iCT have a latch at the base of the system which holds the cover in the closed position. During the course of maintenance the CT Field Service Engineer (FSE) will activate this latching mechanism which in turn has a potential to penetrate the insulation on cabling which carries 277 VAC. If the latch does come into contact with the cabling there is a potential that the FS
Distribution
Worldwide Distribution - USA, including the states: DC, GA, IL, IN, NY and OH; and the countries of Germany and the Netherlands.
Lot / Code Info
M/N 728306, S/N: 100016, 100018 - 100025
Root Cause
Other
Action Taken
Philips Healthcare sent an URGENT - Field Safety Notice letter, dated April 14, 2010, to their customers notifying them of the product, the problem, and the action to be taken. The letter asked them to identify the affected product by checking for the serial number tag (s/n 10016 10025), ensure that the electrical power was shut-down before opening or closing the gantry cover to prevent potential of an electrical shock, and that a Field Service Engineer would contact the facility to make arrangements for the implementation of a Field Change Order (FCO) before December to correct the problem. For further information or support concerning this issue, the customer was instructed to contact their Philips representative: Customer Care Center (1-800-722-9377, option 5 or their local Philips Healthcare Office).