Philips Spectral CT on Rails recall: Software Issue
Philips Spectral CT on Rails. Model Number: 728334.
Why was Philips Spectral CT on Rails recalled?
Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? <Yes> or <No> should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: 728334. UDI: (01)00884838103627(21)1005, (01)00884838103627(21)1006, (01)00884838103627(21)1007. Software Version Number: 5.1.X. Serial Numbers: 1005, 1006, 1007.
- Product
- Philips Spectral CT on Rails. Model Number: 728334.
- Recalling firm
- PHILIPS MEDICAL SYSTEMS
- Quantity
- 3 systems
- Distribution
- Worldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.
- Recall date
- April 22, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)