Medical Device Recall: 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. · May 2, 2024
Reason for Recall
Potential for pressure wave data synchronization from two devices may not be correct.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
391 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1926-2024
Status: ongoing
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