# FDA recall Z-2189-2025

> **PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.** · Class II · device recall initiated 2025-06-30.

## Product

Philips Allura R8.2.x Systems. Software Verion: R8.2.x.     1. Allura Xper FD10, Model Number: 722026.    2. Allura Xper FD10/10, Model Number: 722027.    3. Allura Xper FD20, Model Number: 722028.    4. Allura Xper FD20/10, Model Number: 722029.    5. Allura Xper FD10 OR Table, Model Number: 722033.     6. Allura Xper FD20 OR Table, Model Number: 722035.     7. Allura Xper FD20/20, Model Number: 722038    8. Allura Xper FD20/20 OR Table, Model Number: 722039.     9. Allura Xper FD20/15, Model Number: 722058.     10. Allura Xper FD20/15 OR Table, Model Number: 722059.

## Reason for recall

Potential for temporary loss of imaging (X-ray) functionality due to software issue.

## Distribution

Worldwide - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Georgia, Germany, Greece, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Lao, Lebanon, Lithuania, Malaysia, Maldives, Malta, Martinique, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, T¿rkiye, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Viet

## Key facts

- **Recall number:** Z-2189-2025
- **Recalling firm:** PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-30
- **Report date:** 2025-08-06

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2189-2025

## Citation

> AI Analytics. FDA recall Z-2189-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2189-2025. Source: US FDA. Licensed CC0.

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