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Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and...

FDA Device Recall #Z-1176-2024 — Class II — February 6, 2024

Recall Summary

Recall Number Z-1176-2024
Classification Class II — Moderate risk
Date Initiated February 6, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Location Best, N/A
Product Type Devices
Quantity 14 units

Product Description

Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280

Reason for Recall

Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of NY, PA, PR, TN, TX, VA, WA and the countries of Algeria, Armenia, Austria, Brazil, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Kazakhstan, Korea, Republic of Kuwait, Lithuania, Macao, Macedonia, Malaysia, Morocco, Netherlands, Norway, Oman, Palestine, State of Panama, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom.

Lot / Code Information

OUS: (1) Model: 722221 SN: 66 (01)00884838099203(21)66; SN: 91 (01)00884838099203(21)91; SN: 104 (01)00884838099258(21)104, (2) Model: 722222 SN: UDI: 165 (01)00884838099210(21)165 183 (01)00884838099210(21)183 189 (01)00884838099210(21)189 182 (01)00884838099210(21)182 185 (01)00884838099210(21)185 159 (01)00884838099210(21)159 184 (01)00884838099210(21)184 190 (01)00884838099210(21)190 174 (01)00884838099210(21)174 177 (01)00884838099210(21)177 (3)Model: 722280 20 (01)00884838103276(21)20

Other Recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Recall # Classification Product Date
Z-1346-2026 Class II Azurion 7 B12 System Model Numbers:(1) 722067,... Jan 26, 2026
Z-1350-2026 Class II Azurion 5 M12 System Model Numbers: (1)722227,... Jan 26, 2026
Z-1349-2026 Class II Azurion 7 M20 System Model Numbers: (1)722079,... Jan 26, 2026
Z-1348-2026 Class II Azurion 7 M12 System Model Numbers: (1)722078,... Jan 26, 2026
Z-1345-2026 Class II Azurion 3 M15 System Model Numbers: (1) 722064... Jan 26, 2026

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.

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