Spectral CT on Rails recall: Software Issue
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Why was Spectral CT on Rails recalled?
Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software Version Number 5.1.0; Model number: 728334; UDI-DI: (01)00884838103627(21)1005; Serial Number (SN): 1005;
- Product
- Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
- Recalling firm
- Philips Medical Systems Nederland B.V.
- Quantity
- 1 unit
- Distribution
- Domestic: MN
- Recall date
- March 19, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)