[pending] Philips Spectral CT on Rails. Model Number: 728334.
Pending LLM rewrite. Source: FDA_DEVICE Z-1825-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Philips Spectral CT on Rails. Model Number: 728334.
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 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
Distributed nationwide across the United States.
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