DeviceSignal · Recall classified
PHILIPS MEDICAL SYSTEMS
FDA classified a device recall on 2026-07-27 · Class II · Z-2650-2026
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: Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel…. Recall Z-2650-2026. The firm initiated it on 2026-06-11. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2650-2026
- 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
- Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
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-2650-2026- 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
2b2583b06a126a9ff60c202ad9a9a0b5c7789db4a49e351785e3d3758f705c05- 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)