Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Philips Interventional Hemodynamic Application R.1.2X Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Due to Potential for pressure wave data synchronization from two...
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 Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.
Quantity: 391 units
Why Was This Recalled?
Potential for pressure wave data synchronization from two devices may not be correct.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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