Class 2 Device Recall Spectral CT 7500

• Date Initiated by Firm: August 18, 2026
• Date Posted: September 29, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3155-2026
• Recall Event ID: 99865
• 510(K)Number: K244008
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
• Code Information: UDI: (01)00884838101111
• FEI Number: 3016618143
• Recalling Firm/ Manufacturer: Philips North America Llc; 222 Jacobs St; Cambridge MA 02141-2289
• Manufacturer 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.
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: 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.
• Quantity in Commerce: 62
• Distribution: U.S. and U.S. Territories.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = JAK