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U.S. Department of Health and Human Services

Class 2 Device Recall Philips IQon Spectral CT

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 Class 2 Device Recall Philips IQon Spectral CTsee related information
Date Initiated by FirmAugust 07, 2026
Date PostedSeptember 01, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3041-2026
Recall Event ID 99784
510(K)NumberK193454 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductPhilips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x
Code Information UDI:N/A
FEI Number 3016618143
Recalling Firm/
Manufacturer		 Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionPhilips will inform customers of the issue via an Electronic Product Radiation Correction notification, dated "AUG 2026". Philips will schedule an appointment with remaining customers to update the software free of charge. Customers who need additional information or support concerning this issue should be directed to their local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center). Philips reference: 2025-PD-CTAMI-014.
DistributionUS and US Territories.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JAK
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