Events

Recall of Device Recall Philips ProGrade R1

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Electronics North America Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79139
  • Event Risk Class
    Class 2
  • Event Number
    Z-0704-2018
  • Event Initiated Date
    2017-12-11
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161432
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • 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.
  • 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.

Device

Device Recall Philips ProGrade R1
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution, Internationally to Canada.
  • 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.
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Manufacturer Address
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA