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?
This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363).
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)