# FDA recall Z-1802-2025

> **Philips North America Llc** · Class II · device recall initiated 2025-05-13.

## Product

Product Name: Ingenia Elition S;  Model Numbers: (1) 781357, (2) 782106, (3) 782137;

## Reason for recall

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

## Distribution

Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.

## Key facts

- **Recall number:** Z-1802-2025
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-13
- **Report date:** 2025-05-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cambridge, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1802-2025

## Citation

> AI Analytics. FDA recall Z-1802-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1802-2025. Source: US FDA. Licensed CC0.

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