Philips Spectral CT on Rails software recall due to scanning and movement issues
Philips is recalling one unit of Spectral CT on Rails software version 5.1.0 due to multiple software problems causing scanning issues, image errors, and unintended device movement.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is a Class II FDA recall of a medical imaging device with software issues that create risk of harm through unintended movement and imaging errors. No hospitalization or injury reports are documented in the source material, placing this in the risk-of-harm category where injury has not yet been reported.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling one unit of Spectral CT on Rails (software version 5.1.0, model 728334). The device is distributed in Minnesota.
The recall is due to multiple software problems identified in version 5.1.0. These problems lead to various scanning issues, image errors, and unintended device movement. The software malfunctions can affect the device's proper operation and diagnostic image quality.
The recalled product
- Product
- Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
- Manufacturer
- Philips Medical Systems Nederland B.V.
- Affected units
- 1
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 (4)
- Software Version Number 5.1.0
- Model number: 728334
- UDI-DI: (01)00884838103627(21)1005
- Serial Number (SN): 1005
Distribution
Distributed in 1 state:
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