FDA-Device2026-04-22Class II

Philips Spectral CT on Rails. Model Number: 728334.

PHILIPS MEDICAL 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.

Sold states

Worldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.

Affected count

3 systems

Manufactured in

222 Jacobs St, N/A, Cambridge, MA, United States

Products

Philips Spectral CT on Rails. Model Number: 728334.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1825-2026

Original summary

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

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