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 Jul 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: Aug 14, 2024
Initiation Date: Jul 15, 2024
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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2534-2024
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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