# FDA recall Z-2504-2025

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

## Product

Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers:    1. Allura Xper FD10, Model Number 722003.     2. Allura Xper FD10/10, Model Number 722005.     3. Allura Xper FD20, Model Number 722006.     4. Allura Xper FD20 Biplane, Model Number 722008.     5. Allura Xper FD10, Model Number 722010.     6. Allura Xper FD10/10, Model Number 722011.     7. Allura Xper FD20, Model Number 722012.     8. Allura Xper FD20 Biplane, Model Number 722013.     9. Allura Xper FD20 OR Table, Model Number 722023.     10. Allura Xper FD10, Model Number 722026.     11. Allura Xper FD10/10, Model Number 722027.     12. Allura Xper FD20, Model Number 722028.     13. Allura Xper FD20/10, Model Number 722029.     14. Allura Xper FD20 OR Table, Model Number 722035.     15. Allura Xper FD20/20, Model Number 722038.     16. Allura Xper FD20/15, Model Number 722058.    510(k) Numbers: K102005, K130842, K130638, K133292, K141979, K161563, K16

## Reason for recall

Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.

## Distribution

Worldwide - US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, HI, ID, IL, KS, KY, LA, MI, MN, MO, NC, NJ, NM, NV, NY, OH, OR, PA, TN, TX, UT, VA, WI, WV and the countries of Argentina, Austria, Australia, Belgium, Switzerland, Chile, China, Colombia, Czechia, Germany, Egypt, Spain, Finland, France, United Kingdom, Hong Kong, India, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, Norway, Oman, Pakistan, Poland, Romania, Saudi Arabia, Sweden, Singapore, Thailand, Vietnam.

## Key facts

- **Recall number:** Z-2504-2025
- **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-2504-2025

## Citation

> AI Analytics. FDA recall Z-2504-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2504-2025. Source: US FDA. Licensed CC0.

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