# FDA recall Z-1140-2019

> **Philips Medical Systems Nederlands** · Class II · device recall initiated 2019-02-19.

## Product

Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038    Product The Allura Xper FD Series are intended for use on human patients to perform:   Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.

## Reason for recall

Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or continuous inability of making live fluoroscopy images or exposures.

## Distribution

US Nationwide Distribution in the states of  CA, FL, MI, OR, PA, TX and WA.

## Key facts

- **Recall number:** Z-1140-2019
- **Recalling firm:** Philips Medical Systems Nederlands
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-19
- **Report date:** 2019-04-24
- **Termination date:** 2020-10-14

- **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-1140-2019

## Citation

> AI Analytics. FDA recall Z-1140-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1140-2019. Source: US FDA. Licensed CC0.

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