# FDA recall Z-1795-2021

> **Philips North America Llc** · Class II · device recall initiated 2021-04-23.

## Product

Ingenia Ambition X - Model Number: 781356,  Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X

## Reason for recall

The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by a lifting crane, e.g. during decommissioning or moving activities. A mechanical issue was detected on these hoisting interface blocks on top of the magnet.

## Distribution

Domestic: FL, GA, MI, MO, NH, NJ, NY, PA, SC, TX, VT. Foreign: Australia, Austria, Bangladesh, Belgium, Brazil, Denmark, Finland, France, Germany, Iraq, Italy, Japan, Libya, Moldova, Netherlands, Oman, Spain, Switzerland, Thailand, United Arab Emirates, United Kingdom.

## Key facts

- **Recall number:** Z-1795-2021
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-04-23
- **Report date:** 2021-06-16

- **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-1795-2021

## Citation

> AI Analytics. FDA recall Z-1795-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1795-2021. Source: US FDA. Licensed CC0.

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