Brilliance 64 — Class II medical device recall Z-1143-2019
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2019-04-24. Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or sm
| Recall number | Z-1143-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2018-07-03 |
| Classified | 2019-04-13 |
| Reported by FDA | 2019-04-24 |
| Terminated | 2020-04-17 |
| Countries outside the US | CN, GB |
| Quantity | 14 |
| Reason classes | device malfunction |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1143-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.