FDA-Device2024-06-05Class II
Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Hazard
Potential for pressure wave data synchronization from two devices may not be correct.
Sold states
Worldwide distribution - US Nationwide in the states of CA, IN, OR and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Chile, Costa Rica, C¿te D'Ivoire, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hungary, India, Ireland, Italy, Malaysia, Martinique, Netherlands, New Zealand, Oman, Pakistan, Panama, Poland, R¿union, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Sri Lanka, Switzerland, Thailand, Ukraine, United Kingdom.
Affected count
391 units
Manufactured in
Veenpluis 4-6, Best, Netherlands
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1926-2024Don't want to check this manually?
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