DeviceSignal · Recall classified
Philips North America Llc
FDA classified a device recall on 2026-09-01 · Class II · Z-3043-2026
EventRecall classified
Effective2026-09-01
ClassificationClass II
On 2026-09-01 the FDA classified a device recall from Philips North America Llc as Class II. Product: Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64…. Recall Z-3043-2026. The firm initiated it on 2026-08-07. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3043-2026
- Classification
- Class II
- Classified on
- 2026-09-01
- Initiated on
- 2026-08-07
- Firm
- Philips North America Llc
- Reason
- Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
- Product
- Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-3043-2026- Snapshot hash
2ad9ab6cbee6c5eb2f0d4298731a8c9755893d917528d78bf00a015fa69a0494- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-15T12:38:10.708Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
a6baf1853358f9b5eca954394c7c098386e5f22b79eb5e75a6c2c85b14d32980- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)