DeviceSignal · Recall classified
Philips North America Llc
FDA classified a device recall on 2026-09-01 · Class II · Z-3042-2026
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 Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China…. Recall Z-3042-2026. The firm initiated it on 2026-08-07. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3042-2026
- 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 Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.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-3042-2026- 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
dcc40b5be9766f59d6c9420eded4f7182f89b89360b6179677cbd21633657617- 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)