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 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
