# FDA recall Z-2225-2026

> **PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.** · Class II · device recall initiated 2026-04-28.

## Product

Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers.     1. Azurion 3 M12; Model Numbers: 722063, 722229.     2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230.     3. Azurion 5 M12; Model Numbers: 722227, 722231.     4. Azurion 5 M20; Model Numbers: 722228, 722232, 722281.     5. Azurion 7 B12; Model Numbers: 722067, 722225, 722235.     6. Azurion 7 B20; Model Numbers: 722068, 722226, 722236.     7. Azurion 7 M12; Model Numbers: 722078, 722223, 722233.     8. Azurion 7 M20; Model Numbers: 722079, 722224, 722234, 722282.

## Reason for recall

Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.

## Distribution

Nationwide distribution. International distribution to Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, C¿te D'Ivoire, El Salvador, Estonia, Greece, Honduras, Hong Kong, Iceland, Indonesia, Iraq, Japan, Kyrgyzstan, Malaysia, Malta, Moldova, Nepal, New Zealand, Philippines, Qatar, Singapore, South Africa, Sri Lanka, Syrian Arab Republic, Tanzania, Turkmenistan, Vietnam, Yemen

## Key facts

- **Recall number:** Z-2225-2026
- **Recalling firm:** PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-28
- **Report date:** 2026-05-27

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2225-2026

## Citation

> MORVS. FDA recall Z-2225-2026. Retrieved 2026-10-15 from https://api.morvs.ai/recall/Z-2225-2026. Source: US FDA. Licensed CC0.

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