Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as...
FDA Device Recall #Z-2205-2019 — Class II — July 16, 2019
Recall Summary
| Recall Number | Z-2205-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 16, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips North America, LLC |
| Location | Andover, MA |
| Product Type | Devices |
| Quantity | 834 |
Product Description
Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20 Models: 722063, 722064, 722067, 722068, 722078, 722079. Product Usage: The Azurion series (within the limits of the used Operating Room table) are intended for use to perform: Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: . The Azurion series can be used in a hybrid Operating Room. The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.
Reason for Recall
The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to the mains power supply for more than 50 days, may result in a delay of treatment.
Distribution Pattern
US Nationwide Distribution Foreign: Canada Argentina AUSTRALIA Austria Azerbaijan Bahrain Bangladesh Belgium Bosnia and Herzegovina Brazil Bulgaria Chile Colombia CROATIA Denmark ECUADOR Egypt Finland France Germany Greece Hong Kong India Indonesia Ireland Israel Italie Italy Japan Jordan Kazakhstan Korea, Republic of Latvia Lebanon Libya Malaysia Maldives Mexico Mongolia Myanmar Netherlands New Zealand Norway Oman Pakistan Philippines Polamnd Poland Portugal Republic of Korea Romania Russian Federation Saudi Arabia Serbia Singapore SLOVENIA South Africa Spain Sri Lanka Sweden Switzerland Thailand Tunisia Turkey UNITED ARAB EMI United Arab Emirates United Kingdom Uzbekistan Viet Nam
Lot / Code Information
Software version R1.2
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| Z-0284-2021 | Class II | Philips Sterilizable Defibrillator Paddles, Swi... | Sep 14, 2020 |
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Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.