FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Brilliance 16 Air, 728246 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
- Recall number
- Z-1142-2019
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Brilliance 16 Air, 728246 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
- Status
- Terminated
- Initiated
- 2018-07-03
- Posted
- not on file
- Terminated
- 2020-04-17
- Reason
- 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.
- Root cause
- Device Design
- Action
- On June 29. 2018, the firm sent Customer Information Letters to affected customers. The letter informed customers that Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. Customers were advised to review the user documentation provided with your system related to Quality Assurance checks. If artifacts are detected during review of the images produced by these checks, and are not removed with the recommended steps identified within your user documentation, please contact your service representative before resuming clinical use.
- Quantity
- 23
- Distribution
- Distributed only to China and UK.
- Lot, serial or model codes
- 6143 5701 50069 6232 6563 50007 5928 3466 6301 6328 50048 6145 5560 6324 5908 6520 5924 5496 6507 5944 6351 6149 6562
- 510(k) numbers
- ["K012009"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 1525965
- Firm city
- Cleveland
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28