# FDA recall Z-2502-2025

> **PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.** · Class II · device recall initiated 2025-08-01.

## Product

Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers:     1. Azurion 3 M12, Model Number 722063.     2. Azurion 3 M15, Model Number 722064.     3. Azurion 7 B12, Model Number 722067.     4. Azurion 7 B20, Model Number 722068.     5. Azurion 7 M12, Model Number 722078.     6. Azurion 7 M20, Model Number 722079.     7. Azurion 3 M12, Model Number 722221.     8. Azurion 3 M15, Model Number 722222.     9. Azurion 7 M12, Model Number 722223.     10. Azurion 7 M20, Model Number 722224.     11. Azurion 7 B12, Model Number 722225.     12. Azurion 7 B20, Model Number 722226.     13. Azurion 5 M12, Model Number 722227.     14. Azurion 5 M20, Model Number 722228.     15. Azurion 7 M20, Model Number 722282.

## Reason for recall

Philips Azurion and Allura systems configured  with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.

## Distribution

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Korea, Republic of, Kosovo, Latvia, Lithuania, Macedonia, Maldives, Malta, Mexico, Moldova, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Panama, Paraguay, Peru, Philippines, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam.

## Key facts

- **Recall number:** Z-2502-2025
- **Recalling firm:** PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-01
- **Report date:** 2025-09-10

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2502-2025

## Citation

> AI Analytics. FDA recall Z-2502-2025. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-2502-2025. Source: US FDA. Licensed CC0.

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