Philips Medical Systems recallZ-3155-2026 · Philips North America Llc · initiated Aug 18, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Radiation Control for Health and Safety Act
What the company 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.
Recall details
- Recall number
- Z-3155-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 18, 2026
- Posted by the FDA
- Sep 29, 2026
- Recalling firm
- Philips North America Llc
- Quantity
- 62
- Product code
- JAK
- FDA submissions
- K244008
- Distribution
- U.S. and U.S. Territories.
Product description
Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
Code information (models, lots, serial numbers)
UDI: (01)00884838101111
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Spectral CTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed11 recalls3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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