Device product
Philips Spectral CT on Rails. Model Number: 728334.
Z-1825-2026
Product summary
- Event
- Event 98588
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3 systems
- Official record key
device-enforcement:Z-1825-2026
Official wording
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.
Code information: 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.
Distribution pattern: Worldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.
Derived failure modes
-
Device software or design
software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could