Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 Recall
Issued November 22, 2023 · Philips North America
In November 2023, Philips North America recalled the Spectral CT on Rails, Software Version 5.1.0, Model Number 728334, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Philips North America to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Philips North America
- Category
- Health
- Recall date
- November 22, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the state of MN.
- Recall number
- FDA-Z-0319-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Philips North America has 8 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.