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U.S. Department of Health and Human Services

Class 2 Device Recall System, Xray, Tomography, Computed

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 Class 2 Device Recall System, Xray, Tomography, Computedsee related information
Date Initiated by FirmJune 11, 2026
Date PostedJuly 27, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2651-2026
Recall Event ID 99352
510(K)NumberK193454 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductIQon Spectral CT IQon Spectral CT Upgrades
Code Information FCO72800812; FCO72800814 728331 728332, DI (01)00884838059542
FEI Number 3017726341
Recalling Firm/
Manufacturer		 PHILIPS MEDICAL SYSTEMS
222 Jacobs St
Cambridge MA 02141-2289
For Additional Information Contact
1-800-722-9377
Manufacturer 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.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionAn Electronic Product Radiation Correction letter was issued to its customers describing the product, problem and actions to be taken by its customers. To identify the software version of your product: 1. Click the Help button. 2. Select About and the software version is then displayed. The software version begins with v. 3.You may continue to use your system(s) in accordance with the intended use. 4. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Electronic Product Radiation Correction Letter, understanding of the issues, and required actions to be taken. 5. Circulate this Electronic Product Radiation Correction Letter to all users of this device so that they are aware of the issues. Please retain this letter with your system(s) until a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed. Actions planned by Philips to correct the problem Philips will contact you to schedule a time for a Philips Field Service Engineer (FSE) to visit your site and install the software update to resolve the issues. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377).
Quantity in Commerce42
DistributionUS Nationwide Distribution including Puerto Rico
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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