# FDA recall Z-0002-2026

> **PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.** · Class II · device recall initiated 2025-09-03.

## Product

Allura Xper FD10;  Model Numbers: (1) 722003, (2) 722010, (3) 722026;  Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

## Reason for recall

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

## Distribution

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Ukr

## Key facts

- **Recall number:** Z-0002-2026
- **Recalling firm:** PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-03
- **Report date:** 2025-10-08

- **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-0002-2026

## Citation

> AI Analytics. FDA recall Z-0002-2026. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0002-2026. Source: US FDA. Licensed CC0.

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