PHILIPS MEDICAL SYSTEMS: Philips Spectral CT on Rails. Model Number: 728334.
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- PHILIPS MEDICAL SYSTEMS
- Product
- Philips Spectral CT on Rails. Model Number: 728334.
- Reason / hazard
- 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
- Status
- Ongoing
- Distribution / sold at
- Worldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.
- Recall initiated
- 2026-03-07
- Code info
- 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 quantity
- 3 systems
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Cambridge
- State
- MA
- Country
- United States
- Event id
- 98588
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