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Ongoing FDAEvent 99865 (16 days ago)

Philips Spectral CT 7500

The Spectral CT 7500 software may crash during bolus tracking.

Moderate risk

Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.

FDA Class II recall · How risk is rated

What to do

What happened

Philips North America Llc is recalling the Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333. The Bolus tracking scan application may crash with a system error message, and Bolus Tracker shots may continue even if the contrast threshold is reached, potentially causing additional radiation to the patient. The recall began on August 18, 2026, and was added to the FDA's Enforcement Report on September 29, 2026.

Summary by Recall Canary from the FDA notice.

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Affected if its UDI-DI matches.

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

    UDI-DI
    • 00884838101111

Details

Company began the recall
Sold in

U.S. and U.S. Territories.

Event ID
99865
Recall No.
Z-3155-2026
Company
Philips North America LlcCambridge, Massachusetts
  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. Summary updated

  5. In FDA's weekly enforcement report

All recalls from Philips North America Llc

Summary by Recall Canary, written with AI · summary updated Oct 3, 2026 · primary source: U.S. Food and Drug Administration