# FDA recall Z-0704-2018

> **Philips Electronics North  America Corporation** · Class II · device recall initiated 2017-12-11.

## Product

digital x-ray detector    ProGrade R1 - solid state X ray imager (flat panel/digital imager)    As a part of a radiographic system, the Philips ProGrade is intended to acquire, process, store, display, and export digital radiographic images. The Philips ProGrade is suitable for all routine radiographic examinations, including specialist area like intensive care, trauma, or pediatric work, excluding mammography. United States only: The Eleva Workspot is not intended for fluoroscopy and angiography.

## Reason for recall

It the WiFi connection between the SkyPlate detector and HP transfer point is weak, an image may fail to transfer from the SkyPlate detector to the system.  The image remains in the memory of the detector, but cannot be transferred wirelessly or by use of the backup cable. To continue, the operator can reset the SkyPlate detector by removing its batteries, but the acquired image is lost and a  re-take is necessary.

## Distribution

Worldwide Distribution - USA (nationwide) Distribution,  Internationally to Canada.

## Key facts

- **Recall number:** Z-0704-2018
- **Recalling firm:** Philips Electronics North  America Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-11
- **Report date:** 2018-03-07
- **Termination date:** 2020-05-29

- **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-0704-2018

## Citation

> AI Analytics. FDA recall Z-0704-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0704-2018. Source: US FDA. Licensed CC0.

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