- Recalling firm
- PHILIPS MEDICAL SYSTEMS
- 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.
- Affected products (lot / model / serial)
- 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.
- Units affected
- 3 systems
- Distribution pattern
- Worldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.
- Firm location
- Cambridge, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1825-2026
- Recall initiated
- March 7, 2026
- FDA classification date
- April 16, 2026
- FDA report date
- April 22, 2026
- FDA event ID
- 98588
- Last updated on HTM Vibe
- July 24, 2026