Recall Z-2651-2026— PHILIPS MEDICAL SYSTEMS

Name: FDA recall Z-2651-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-11

Class II · Ongoing

Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS, initiated 2026-06-11. It names one FDA 510(k) clearance: K193454. 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..

Recalling firm: PHILIPS MEDICAL SYSTEMS
Classification: Class II
Status: Ongoing
Initiated: 2026-06-11
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K193454 — IQon Spectral CTPhilips Medical Systems Nederland B.V.·cleared 2020-01-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

IQon Spectral CT IQon Spectral CT Upgrades

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.