Philips Spectral CT on Rails Model 728334 recalled for software defects affecting scan operations
Philips has identified three software issues in the Spectral CT on Rails Model 728334 that may affect scan operations. The gantry (rotating scanner) may not move to the correct position after pressing start; a required confirmation message may not appear; and a menu option may become unavailable during brain imaging setup. Three systems worldwide are affected.
From the FDA notice · Read the official notice ↗ · All Philips recalls
What to do
- Contact Philips Medical Systems immediately if you operate this model
- Do not perform scans until you receive guidance from Philips
- Request a software update from your Philips representative
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Philips Spectral CT on Rails. Model Number: 728334.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 3 systems
- Illnesses reported
- None reported
- Manufactured in
- 222 Jacobs St, N/A, Cambridge, MA, United States
- Classification
- Class II
- Recall number
- Z-1825-2026
In the FDA's words
- Description
- Philips Spectral CT on Rails. Model Number: 728334. 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. 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: Worldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands. Affected quantity: 3 systems
- 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.