DeviceSignal · Recall classified
Philips North America Llc
FDA classified a device recall on 2026-09-01 · Class II · Z-3041-2026
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 IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT…. Recall Z-3041-2026. The firm initiated it on 2026-08-07. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3041-2026
- 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 IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.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-3041-2026- 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
c9b3330f3f54acf751a9289275153b2433473a8521c5aa832af88aaf3da9b5ea- 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)