Spectral CT on Rails recall: Software Issue
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Why was Spectral CT on Rails recalled?
When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.
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?
UDI-DI: 00884838103627; Lot Code: 1005
- Product
- Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
- Recalling firm
- Philips North America
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of MN.
- Recall date
- November 22, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)