Z-1144-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2019
- Initiation Date
- July 3, 2018
- Termination Date
- April 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
Brilliance iCT, 728306 Product Usage: Computed Tomography X-ray systems 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
Reason for Recall
Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator being past its lifetime expected usage.
Distribution Pattern
Distributed only to China and UK.
Code Information
85028 100094