FDA-Device2026-10-07Class IIPROCESSING DEFECT
Philips Spectral CT 7500 software recalled for excessive radiation risk from bolus tracking malfunction
What this means
The bolus tracking application on Philips Spectral CT 7500 scanners (Software V5.2.x) can malfunction and continue taking imaging shots even after reaching the contrast threshold. This can cause patients to receive unintended additional radiation during CT scans.
- Contact Philips Medical Systems for a software update or patch.
- Do not use the bolus tracking feature until the issue is resolved.
- Review recent imaging records for potentially affected scans and consult with your radiologist if needed.
The agency's original wording
Hazard
The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation.
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. and U.S. Territories.
Affected count
62
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3155-2026More Philips recalls
- FDA-Device2026-09-30Philips Ingenia 3.0T MRI systems recalled for software image reconstruction failure
- FDA-Device2026-09-30Philips SmartPath MRI software recalled for exam termination risk
- FDA-Device2026-09-30Philips Achieva 1.5T MRI systems recalled for software issue causing exam termination
- FDA-Device2026-09-30Philips Ingenia Ambition MRI systems recalled for software crash during image processing
- FDA-Device2026-09-30Philips Intera 1.5T MRI systems recalled for software examination termination risk
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