DeviceSignal · Recall classified
PHILIPS MEDICAL SYSTEMS
FDA classified a device recall on 2026-07-27 · Class II · Z-2652-2026
EventRecall classified
Effective2026-07-27
ClassificationClass II
On 2026-07-27 the FDA classified a device recall from PHILIPS MEDICAL SYSTEMS as Class II. Product: Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium…. Recall Z-2652-2026. The firm initiated it on 2026-06-11. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2652-2026
- Classification
- Class II
- Classified on
- 2026-07-27
- Initiated on
- 2026-06-11
- Firm
- PHILIPS MEDICAL SYSTEMS
- Reason
- The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.
- Product
- Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil
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-2652-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
49a05812b8d0635e901a91b7bd136d0afddf55b424d1e6431598a8f2f5c1b767- 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)