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U.S. Department of Health and Human Services

Class 2 Device Recall Philips ProGrade R1

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  Class 2 Device Recall Philips ProGrade R1 see related information
Date Initiated by Firm December 11, 2017
Create Date February 23, 2018
Recall Status1 Terminated 3 on May 29, 2020
Recall Number Z-0704-2018
Recall Event ID 79139
510(K)Number K141736  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
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.
Code Information ProGrade R1, solid state X ray imager, 712090 Serial #s: SN17000011 SN15000026 SN17000022 SN15000038 SN16000001 SN14000035 SN17000020 SN17000003 SN17000008 SN17000013 SN14000024 SN14000034 SN15000012 SN15000024 SN15000022 SN16000035 SN17000018 SN17000024 SN15000049 SN16000006 SN16000010 SN17000001 SN17000023 SN15000042 SN16000011 SN16000020 SN14000007 SN17000025 SN15000051 SN15000028 SN17000014 SN15000016 SN15000035 SN17000015 SN16000041 SN16000022 SN16000007 SN15000005 SN16000009 SN16000040 SN15000046 SN16000016 SN16000015 SN14000013 SN15000006 SN17000030 SN16000012 SN16000014 SN15000039 SN16000039 SN14000028 SN15000032 SN16000042 SN17000021 SN15000013 SN17000007 SN15000047 SN16000024 SN17000002 SN17000005 SN14000022 SN17000004 SN16000030 SN16000031 SN16000032 SN14000006 SN15000033 SN16000021 SN16000029 SN14000016 SN15000031 SN14000003 SN14000014 SN15000019 SN14000023 SN16000019 SN16000038 SN16000017 SN16000004 SN14000017 SN15000007 SN16000036 SN16000037 SN15000029 SN15000050 SN15000009 SN17000010 SN14000029 SN14000032 SN15000053 SN14000015 SN16000034 SN14000001 SN15000004 SN15000014 SN16000002 SN14000026 SN14000005 SN14000021 SN14000019 SN15000045 SN15000030 SN15000036 SN15000025 SN14000033 SN15000001 SN15000002 SN16000018 SN17000012 SN17000016 SN14000020 SN15000043 SN16000033 SN14000008 SN16000027 SN14000031 SN15000003 SN15000008 SN15000017 SN15000027 SN14000025 SN15000044 SN16000023 SN14000004 SN15000041 SN16000028 SN14000010 SN14000018 SN16000013 SN14000027 SN16000043 SN15000015 SN15000011 SN15000040 SN16000003 SN14000011 SN14000012 SN14000009 SN15000037 SN16000005 SN15000020 SN15000023 SN14000030 SN15000018 SN17000006 SN16000026 SN15000034 SN17000026 SN15000052 SN15000010 SN15000048 SN15000054 SN15000055 SN16000008 SN17000009 SN16000025 SN15000021 
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Michael Mizrachi
978-659-7275
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 157
Distribution Worldwide Distribution - USA (nationwide) Distribution, Internationally to Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = PHILIPS MEDICAL SYSTEMS DMC GMBH
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