digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital imager) As a part of a…
Medical device recall Z-0704-2018. Published in FDA’s Enforcement Report on Mar 7, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 7, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 157 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
157, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,783 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - USA (nationwide) Distribution, Internationally to Canada.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 11, 2017.
- FDA classified it on Feb 23, 2018.
- FDA’s Enforcement Report published it on Mar 7, 2018.
- FDA terminated it on May 29, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips Electronics North America Corporation, of Andover, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.