Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Philips Azurion system Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Due to Philips has identified two (2) software issues affecting...
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 MEDICAL SYSTEMS NEDERLAND B.V. directly.
Affected Products
Philips Azurion system; Software Version Number: R3.1;
Quantity: 228 units (all OUS)
Why Was This Recalled?
Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand.
Where Was This Sold?
This product was distributed to 9 states: AZ, AR, CO, DE, ID, IL, IN, MA, MO
About PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 154 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report