Z-1825-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 22, 2026
- Initiation Date
- March 7, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 systems
Product Description
Philips Spectral CT on Rails. Model Number: 728334.
Reason for Recall
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.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.
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.