# FDA recall Z-0559-2024

> **PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.** · Class II · device recall initiated 2023-11-03.

## Product

Philips Azurion systems with monoplane fixed ceiling mounts:  722078 Azurion 7 M12  722079 Azurion 7 M20  722223 Azurion 7 M12  722224 Azurion 7 M20  722227 Azurion 5 M12  722228 Azurion 5 M20

## Reason for recall

Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose

## Distribution

Worldwide - US Nationwide and the countries of Albania, Algeria, Argentina, Australia,  Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, CANADA, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic,  Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Gabon, Georgia,  Germany, Ghana, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong,  Hungary, Iceland, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Japan, Jordan,  Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Latvia, Latvia, Republic of Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Martinique, Mauritius,  Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand,  Nicaragua, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea,  Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, 

## Key facts

- **Recall number:** Z-0559-2024
- **Recalling firm:** PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-03
- **Report date:** 2023-12-27

- **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-0559-2024

## Citation

> AI Analytics. FDA recall Z-0559-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0559-2024. Source: US FDA. Licensed CC0.

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