Reported Apr 22, 2026 · Ongoing
Philips Spectral CT on Rails. Model Number: 728334.
Philips Medical Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PHILIPS MEDICAL SYSTEMS · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- Philips Spectral CT on Rails
- Model Number728334
- Lot codes and dates
- Model Number728334
- UDI
(01)00884838103627(21)1005(01)00884838103627(21)1006(01)00884838103627(21)1007
- Software Version Number5.1.X
- Serial Numbers
100510061007
- Amount recalled
- 3 systems
Where it was sold
- Nationwide
- MN
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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