Z-1143-2019 Class II Terminated
FDA device recall Z-1143-2019 was initiated by Philips Medical Systems (Cleveland) Inc on Jul 3, 2018 and is designated Class II. 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… The recall status is terminated (terminated Apr 17, 2020). Affected quantity: 14.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 24, 2019
- Initiation Date
- Jul 3, 2018
- Termination Date
- Apr 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14
Product Description
Brilliance 64, 728231 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
10011 95620 10436 95486 95391 95838 95807 95621 10521 10255 10006 10715 10275 10616
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1143-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026