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System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nico...

FDA Device Recall #Z-3167-2024 — Class II — August 22, 2024

Recall Summary

Recall Number Z-3167-2024
Classification Class II — Moderate risk
Date Initiated August 22, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Location Best
Product Type Devices
Quantity 250 units

Product Description

System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris Allura 9 722017 Integris H5000 F / Allura 9F 722016 Integris H5000 C / Allura 9C

Reason for Recall

Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.

Distribution Pattern

Nationwide, Canada and Worldwide: Albania Algeria Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Brazil Brunei Darussalam Bulgaria Cambodia Cayman Islands Chile China Colombia Costa Rica C¿te D'Ivoire Croatia Cuba Curacao Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt Estonia Ethiopia Fiji Finland France French Polynesia Georgia Germany Ghana Gibraltar Greece Guadeloupe Guinea Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Israel Italy Jamaica Japan Jordan Kazakhstan Kenya Korea, Republic of Kosovo Kuwait Kyrgyzstan Lao People's Democratic Republic Latvia Lebanon Libya Lithuania Macao Macedonia Malaysia Maldives Malta Martinique Mauritania Mauritius Mexico Mongolia Morocco Myanmar Nepal Netherlands New Caledonia New Zealand Nicaragua Norway Oman Pakistan Palestine, State of Panama Papua New Guinea Paraguay Peru Philippines Poland Portugal Qatar R¿union Romania Russian Federation Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sudan Sweden Switzerland Syrian Arab Republic Taiwan Tanzania Thailand Trinidad and Tobago Tunisia Turkey Turkmenistan Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Venezuela Viet Nam Virgin Islands (U.S.) Yemen

Lot / Code Information

Model Product UDI-DI: N/A 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris Allura 9 722017 Integris H5000 F / Allura 9F 722016 Integris H5000 C / Allura 9C All serial numbers

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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