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.
FDA Recall Z-0704-2018 · Posted None
Advertisement
Recalling FirmPhilips Electronics North America Corporation
Recall StatusTerminated
Product CodeMQB
Date Initiated2017-12-11
Date Terminated2020-05-29
Product Quantity157
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.
Firm Action
Philips sent an Urgent- Field Safety Notice date December 11, 2017.
Philips plans to release a new HP firmware to the installed base. In addition the existing Access Point Hardware in the field needs to be patched. A Philips Service Engineer will contact the affected Customers when the Field Action Kit is available to be implemented. For further questions, please call (978) 659-7275.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide Distribution - USA (nationwide) Distribution, Internationally to Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement