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Recall Observatory FDA recall evidence

Device product

Philips Spectral CT on Rails. Model Number: 728334.

Z-1825-2026

March 07, 2026

Class II

Product summary

Firm
PHILIPS MEDICAL SYSTEMS
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

    reason.device_software_design · v1.0.0

    software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could