# FDA recall Z-0875-2019

> **Philips Medical Systems Nederlands** · Class II · device recall initiated 2018-12-21.

## Product

Intera 1.0T Omni/Stellar, Model Number 781102.   Nuclear Magnetic Resonance Imaging System

## Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

## Distribution

U.S. Nationwide distribution.

## Key facts

- **Recall number:** Z-0875-2019
- **Recalling firm:** Philips Medical Systems Nederlands
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-12-21
- **Report date:** 2019-03-06
- **Termination date:** 2020-11-19

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0875-2019

## Citation

> AI Analytics. FDA recall Z-0875-2019. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/Z-0875-2019. Source: US FDA. Licensed CC0.

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