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Open, Classified

Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333

FDA Recall Z-3155-2026 · Posted 2026-09-29

Recalling FirmPhilips North America Llc
Recall StatusOpen, Classified
Product CodeJAK
Date Initiated2026-08-18
Product Quantity62

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.

Firm 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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

U.S. and U.S. Territories.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K244008Spectral CTPhilips Medical Systems Technologies , Ltd. · 2025-05-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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