Company:Philips Electronics North America Corporation
Date of Enforcement Report 3/7/2018
Class lI:
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.
Recall Number Z-0704-2018
REASON
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.
RECALLING FIRM/MANUFACTURER
Philips Electronics North America Corporation, Andover, MA on 12/11/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
157
DISTRIBUTION
Nationwide and Canada
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