Recall Z-0704-2018— Philips Electronics North America Corporation

Name: FDA recall Z-0704-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-11

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2017-12-11, terminated 2020-05-29. It names one FDA 510(k) clearance: K141736. 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: 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: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-12-11
Terminated: 2020-05-29
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K141736 — PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOSTPhilips Medical Systems Dmc GmbH·cleared 2014-07-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.