# FDA recall Z-1056-2019

> **Philips North  America, LLC** · Class II · device recall initiated 2019-02-28.

## Product

URODiagnost Eleva, Product codes 708026, 708027, 708028    Product Usage:  The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include:   Gastro-intestinal examination   Urography   Bronchography   Arthrography   Hysterography   Myelography   Lymphography   Skeletal radiography   Tomography   Venography/phlebography Special procedures that require subtracted and non-subtracted digital imaginginclude:   Angiography   Peripheral angiography (bolus chasing) Vascular and non-vascular interventional procedures.

## Reason for recall

The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.

## Distribution

US Nationwide domestic distribution, and worldwide international distribution.

## Key facts

- **Recall number:** Z-1056-2019
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-28
- **Report date:** 2019-04-03
- **Termination date:** 2020-08-03

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1056-2019

## Citation

> AI Analytics. FDA recall Z-1056-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1056-2019. Source: US FDA. Licensed CC0.

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