# FDA recall Z-2534-2024

> **PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.** · Class II · device recall initiated 2024-07-15.

## Product

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

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,

## Key facts

- **Recall number:** Z-2534-2024
- **Recalling firm:** PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-07-15
- **Report date:** 2024-08-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Best, Netherlands

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2534-2024

## Citation

> AI Analytics. FDA recall Z-2534-2024. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-2534-2024. Source: US FDA. Licensed CC0.

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