# FDA recall Z-1209-2026

> **Philips North America** · Class II · device recall initiated 2025-12-03.

## Product

Ingenia Ambition S.   Product Code (REF): 782108.   MR systems with SW version R11.1 and R12.1.

## Reason for recall

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

## Distribution

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.

## Key facts

- **Recall number:** Z-1209-2026
- **Recalling firm:** Philips North America
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-03
- **Report date:** 2026-02-04

- **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-1209-2026

## Citation

> AI Analytics. FDA recall Z-1209-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1209-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*