Reported Dec 1, 2021 · Ongoing
Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
Philips Healthcare
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Healthcare · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
- Lot codes and dates
- Azurion 2.1(L1) and 2.1(L2)
- Amount recalled
- 226 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This product extends the functionality of compatible X-ray equipment with the capability of 3D X-ray imaging. Before starting a 3D-RA scan, the detector of the Philips Azurion system must be positioned in portrait or landscape orientation with an angle of 0 or +/-90 degrees relative to the 3D scan direction. Philips has discovered that Azurion releases 2.1(L1) and 2.1(L2) allow creation of a 3D-RA scan with a deviating detector orientation of up to 3 degrees from the exact portrait or landscape orientation (i.e., at 0 or +/-90 degrees), relative to the 3D scan direction. 3D-RA scans with a deviating detector orientation of ore than 1.0 degree from the exact portrait or landscape orientation (i.e., at 0 or +/-90 degrees) cannot be reconstructed with the 3D-RA reconstruction software.
This product could cause temporary or reversible health problems — stop using it.
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