PHILIPS MEDICAL SYSTEMS — Philips Spectral CT on Rails. Model Number: 728334.
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 7, 2026
Worldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.
What's affected?
- Product
- Philips Spectral CT on Rails. Model Number: 728334.
- Lot code
- 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.
Additional details
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.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3 systems.
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