FDA Device recall Z-2651-2026
IQon Spectral CT IQon Spectral CT Upgrades
- FDA Device
- Class II
- ongoing
- Published 2026-08-05
On 2026-08-05 the FDA classified a Class II recall of IQon Spectral CT IQon Spectral CT Upgrades by Philips Medical Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2651-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-11 |
| Published | 2026-08-05 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Philips Medical Systems |
| Distribution | US |
Product
IQon Spectral CT IQon Spectral CT Upgrades
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.
Identifiers
| code_info | FCO72800812; FCO72800814 728331 728332, DI (01)00884838059542 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
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All Philips Medical Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2651-2026%22
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