Philips North America LLC recalls Philips Medical Systems Technologies Ltd. Spectral CT 7500
Reason for recall
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
Lot / code information
- UDI
- (01)00884838101111
What the firm is doing
Philips sent an Electronic Product Radiation Correction notification dated August 18, 2026 to the users of the affected systems to alert them of the issue and provide the actions that should be taken in order to prevent risks to patients. Philips will schedule an appointment with customers to install a software solution free of charge.
DistributionShow detailsHide
U.S. and U.S. Territories.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3155-2026
- FDA 510(k) clearance · K244008The device's official FDA premarket clearance record
- FDA device classification · JAKOfficial FDA classification for this device type
- CFR regulation · 21 CFR 892.1750The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Philips North America LlcSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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