# FDA recall Z-0558-2024

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

## Product

Philips Allura  systems with monoplane fixed ceiling mounts:  722001 Allura Xper FD10C  722003 Allura Xper FD10  722006 Allura Xper FD20  722010 Allura Xper FD10  722012 Allura Xper FD20  722015 Allura Xper FD20 OR Table  722016 Integris H5000 C / Allura 9C  722018 Integris Allura 9  722022 Allura Xper FD10 OR Table  722023 Allura Xper FD20 OR Table  722026 Allura Xper FD10  722028 Allura Xper FD20  722033 Allura Xper FD10 OR Table  722035 Allura Xper FD20 OR Table  722043 Integris Allura 15 & 12 (monoplane)  72246 Poly G - OMCP - VISUB - CCD (H5000)

## 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-0558-2024
- **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-0558-2024

## Citation

> AI Analytics. FDA recall Z-0558-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0558-2024. Source: US FDA. Licensed CC0.

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