PHILIPS MEDICAL SYSTEMS recalls Philips Spectral CT on Rails.
- Recalling company
- PHILIPS MEDICAL SYSTEMS
- Product
- Philips Spectral CT on Rails. Model Number: 728334.
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 7, 2026
- Reported
- Apr 22, 2026
- Distribution
- Worldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.
- Status
- Ongoing
- Quantity
- 3 systems
- Lot / codes
- 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.
- Company location
- Cambridge, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1825-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1825-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.