Device recalls

IQon Spectral CT IQon Spectral CT Upgrades

PHILIPS MEDICAL SYSTEMS · 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 occ…

Open, ClassifiedRadiation Control for Health and Safety ActZ-2651-2026
Open FDA's page for this record
Cfres ID
221398
Product res number
Z-2651-2026
Event date initiated
2026-06-11
Event date posted
2026-07-27
Recall status
Open, Classified
Res event number
99352
Product code
JAK
Product description
IQon Spectral CT IQon Spectral CT Upgrades
Code info
FCO72800812; FCO72800814 728331 728332, DI (01)00884838059542
Firm FEI number
3017726341
Recalling firm
PHILIPS MEDICAL SYSTEMS
Address 1
222 Jacobs St
City
Cambridge
State
MA
Postal code
02141-2289
Additional info contact
1-800-722-9377
Root cause description
Radiation Control for Health and Safety Act
Product quantity
42
Distribution pattern
US Nationwide Distribution including Puerto Rico
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.

Action

An 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).

K numbers
K193454
Harmonized identifiers (openFDA)
Device name
System, X-Ray, Tomography, Computed
Medical specialty description
Radiology
Regulation number
892.1750
Device class
2
K number
K213999, K910859, K193073, K063184, K093146, K123500, K090991, K792603, K160350, K033502, K982265, K964890, K120833, K974513, K222819, K884671, K871859, K991766, K812509, K132410, K761330, K151673, K241713, K072606, K142222, K884788, K232155, K942040, K153429, K183202, K073373, K120546, K173821, K240369, K803181, K133424, K974344, K161157, K013214, K894888 +784 more
Registration number
3017425975, 3004056159, 3008632256, 8022257, 3003678543, 3023003446, 3033527283, 3015223550, 3017210169, 9617978, 3027339477, 3001722928, 3013679558, 3019216, 3017426576, 1226188, 3003967489, 3023140882, 3012761544, 3006209933, 9611343, 3015777306, 3033527273, 2520313, 3002808157, 3042175844, 3008355361, 3004083736, 3010398867, 3012453401, 3039211310, 3005930550, 3042172882, 3012938564, 8043933, 3012044688, 3004753774, 3031503890, 3004977335, 3013035022 +126 more
FEI number
3004056159, 3008632256, 3003678543, 3023003446, 3033527283, 3015223550, 3017210169, 3002807880, 3001726808, 3027339477, 3001722928, 3013679558, 3019216, 3017426576, 3004571294, 3003967489, 1000139922, 3023140882, 3012761544, 3006209933, 3033527273, 3015777306, 2520313, 3002808157, 3008355361, 3004083736, 3010398867, 3012453401, 3039211310, 3002619595, 3005930550, 3042172882, 1000514697, 3012938564, 3003757840, 3012044688, 3004753774, 3031503890, 3002807903, 3004977335 +126 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.