Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot Recalled by Philips North America, LLC Due to When a user acquires XperCT scan on an...
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 North America, LLC directly.
Affected Products
Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoroscopic x-ray system System code: 722079
Quantity: 22 units (6 US and 16 OUS); Expanded 3units; Total: 25
Why Was This Recalled?
When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and moves the L-arm away from the initial scan position before starting the live guidance, a warning message directs the user to move the L-arm stand back to the initial XperCT scan position. Although the software generates this message, it does not prevent the use of live guidance if the L-arm stand is not repositioned. Using live guidance with a mispositioned L-arm can result in the display of an incorrect overlay and needle path.
Where Was This Sold?
This product was distributed to 6 states: FL, ID, IL, IN, MA, OH
About Philips North America, LLC
Philips North America, LLC has 88 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report