Recall Z-0704-2018 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Electronics North America Corporation
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 ma
| Date | Dec 11, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by 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. |
| Quantity | 157 |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution, Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141736 | PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST Philips Medical Systems Dmc GmbH, Jul 25, 2014 |