Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Philips X-Ray Systems Recalled by Philips Electronics North America Corporation Due to Upon initiating Fluoroscopy the user may encounter a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips Electronics North America Corporation directly.
Affected Products
Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology (EP). The Allura Xper FD2O, Allura Xper FD2O/10 and Allura Xper FD2O/20 is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures.
Quantity: 196 devices
Why Was This Recalled?
Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips Electronics North America Corporation
Philips Electronics North America Corporation has 160 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report