Home / Recalls / PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. / Z-2534-2024

Z-2534-2024 Class II Ongoing

Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Best

FDA device recall Z-2534-2024 was initiated by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on July 15, 2024 and is designated Class II. Reason for recall: Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart The recall status is ongoing. Affected quantity: 3011 units.

Recall Details

Product Type: Devices
Report Date: August 14, 2024
Initiation Date: July 15, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3011 units

Product Description

Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular, and neuro procedure. Model Numbers: 722063, 722064, 722067, 722068, 722078 and 722079

Reason for Recall

Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Malaysia, Maldives, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan Palestine, State of Peru, Philippines, Poland, Portugal, R¿union Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam.

Code Information

Model /UDI-DI: (1) 722063 (01)00884838085275(21); (2) 722064 (01)00884838085282(21); (3) 722067 (01)00884838085350(21); (4) 722068 (01)00884838085367(21); (5) 722078 (01)00884838085251(21); (6) 722079 (01)00884838085268(21). Software Version Number: R1.0, R1.1, R1.2

Other recalls by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Z-2411-2026 Class II — Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 (May 18, 2026)
Z-2412-2026 Class II — Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura (May 18, 2026)
Z-2259-2026 Class II — Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003 (April 30, 2026)
Z-2258-2026 Class II — Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, (April 30, 2026)
Z-2229-2026 Class II — Integris-Allura system; System Code Description (Model Numbers): Integris CV Ces (April 28, 2026)
Z-2227-2026 Class II — Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), (April 28, 2026)
Z-2225-2026 Class II — Philips Azurion systems not configured with an optional auxiliary pan handle. In (April 28, 2026)
Z-2228-2026 Class II — Allura system; System Code Description (Model Numbers): Allura Xper FD10C (72200 (April 28, 2026)
Z-2170-2026 Class II — Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, (March 31, 2026)
Z-1805-2026 Class II — Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medic (March 19, 2026)