FDA recall, , Moderate risk
Philips Spectral CT on Rails
Philips Spectral CT on Rails has software issues that could cause the gantry to remain at the current scan position.
Summary by Recall Canary from the FDA notice
What happened
Philips Medical Systems, based in Cambridge, Massachusetts, is recalling the Philips Spectral CT on Rails, model number 728334, because of three software issues. One issue is that during a continuous CT (CCT) scan, the Gantry could remain at the current scan position after pressing Go. Another is a potential where the message "Previous Surview Exists Select Previous Surview?" should display but does not appear. The recall covers three systems and was begun by the company on March 7, 2026.
The FDA added the recall to its Enforcement Report and classified it on April 16, 2026, and it appeared in the FDA's weekly enforcement report on April 22, 2026. The distribution includes the states of Minnesota and the countries of France and Netherlands.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Philips Spectral CT on Rails.
- Model
- 728334
- UDI-DI
- 00884838103627
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.
- Company
- PHILIPS MEDICAL SYSTEMSCambridge, Massachusetts
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98588
- Recall number
- Z-1825-2026
- Quantity recalled
- 3 systems
All recalls from PHILIPS MEDICAL SYSTEMS
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
