Philips Electronics North America Corporation recalls digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital imager) As a part of a radiographic s…

Recall date

December 11, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0704-2018

FDA classification

Class II

Brand / firm

Philips Electronics North America Corporation

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.