Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.
Reported: June 5, 2024 Initiated: May 2, 2024 #Z-1926-2024
Product Description
Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.
Reason for Recall
Potential for pressure wave data synchronization from two devices may not be correct.
Details
- Recalling Firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Units Affected
- 391 units
- 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.
- Location
- Best
Frequently Asked Questions
What product was recalled? ▼
Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.. Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Units affected: 391 units.
Why was this product recalled? ▼
Potential for pressure wave data synchronization from two devices may not be correct.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 5, 2024. Severity: Moderate. Recall number: Z-1926-2024.
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