# FDA recall Z-1079-2026

> **PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.** · Class II · device recall initiated 2025-12-08.

## Product

Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models:    1. Azurion 3 M12. Model Number: 722229.     2. Azurion 3 M15. Model Number: 722230.     3. Azurion 5 M12. Model Number: 722231.     4. Azurion 5 M20. Model Number: 722232.     5. Azurion 7 B12. Model Number: 722235.     6. Azurion 7 B20. Model Number: 722236.     7. Azurion 7 M12. Model Number: 722233.     8. Azurion 7 M20. Model Number: 722234.

## Reason for recall

Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.

## Distribution

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Chile, Colombia, Cote de'Ivore, Croatia, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Kazakhstan, Kosovo, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mauritius, Morocco, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Palestine, Philippines, Poland, Portugal, R¿union, Romania, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkiye, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Vietnam, Yemen.

## Key facts

- **Recall number:** Z-1079-2026
- **Recalling firm:** PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-08
- **Report date:** 2026-01-21

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1079-2026

## Citation

> AI Analytics. FDA recall Z-1079-2026. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1079-2026. Source: US FDA. Licensed CC0.

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