Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029,…
Medical device recall Z-0239-2019. Published in FDA’s Enforcement Report on Oct 31, 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 Oct 31, 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
- 829 units 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?
Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts after first image; System software CD contains wrong baseline
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 712225, 712226, 712227, 712228.
829 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Software 4.1.x and 4.2.x Serial Numbers: 547772/SN14000040 549865/SN14000071 SN14000090 554080/SN15000110 SN15000165 SN15000174 SN15000173 SN15000180 SN15000189 SN15000190 SN15000192 SN15000196 SN15000225 SN15000264 SN15000281 SN15000283…
Every code shown here, 1,994 characters
Software 4.1.x and 4.2.x Serial Numbers: 547772/SN14000040 549865/SN14000071 SN14000090 554080/SN15000110 SN15000165 SN15000174 SN15000173 SN15000180 SN15000189 SN15000190 SN15000192 SN15000196 SN15000225 SN15000264 SN15000281 SN15000283 SN15000282 SN15000288 SN15000291 SN15000298 SN15000304 SN15000303 SN15000327 SN15000153 SN15000152 SN15000350 563654/SN15000364 SN15000355 SN15000364 SN15000371 SN15000372 SN15000374 SN15000373 SN15000379 SN15000433 SN15000443 SN15000442 SN15000444 SN15000449 SN16000008 SN16000023 SN16000025 SN16000037 SN16000043 SN16000050 SN16000063 SN16000073 SN16000095 SN16000092 SN16000105 SN16000104 SN16000113 SN16000112 SN16000123 SN16000124 SN16000137 SN16000143 SN16000142 SN15000211 SN16000146 SN16000147 SN16000151 SN16000151 SN16000156 SN16000158 SN16000165 SN16000191 SN16000197 SN16000214 SN16000225 SN16000234 SN16000236 SN16000237 571802/SN16000253 SN16000253 SN16000263 SN16000264 SN16000271 SN16000283 SN16000296 SN16000297 SN16000302 SN16000308 SN16000310 SN16000311 SN16000321 SN16000329 SN16000328 SN16000343 SN16000347 SN16000352 SN16000355 SN16000371 SN16000375 SN16000386 SN16000387 SN16000390 SN16000394 SN16000395 SN16000398 SN16000402 SN16000418 SN16000421 SN16000430 SN16000435 61 SN16000465 SN17000024 SN17000027 SN17000034 SN17000038 SN17000044 SN17000045 SN17000058 SN17000070 SN17000084 SN17000090 SN17000092 SN17000100 SN17000107 SN17000106 SN17000114 SN17000126 SN17000127 SN17000141 SN17000151 SN17000150 SN17000166 SN17000171 SN17000185 SN17000190 SN17000147 SN17000160 SN17000216 SN17000217 SN17000231 SN17000235 SN17000263 SN17000264 SN17000262 SN17000278 SN17000283 SN17000289 SN17000288 SN17000294 SN17000295 SN17000311 SN17000305 SN17000317 SN17000326 SN17000329 SN17000335 SN17000303 SN17000334 SN17000342 SN17000346 SN17000349 SN17000352 SN17000351 SN17000359 SN17000362 SN17000376 SN17000373 SN17000372 SN17000395 SN17000399 SN17000398 SN17000414 SN17000411 SN17000422 SN17000436/ SN18000001 SN17000005 SN18000007 SN18000025…
FDA’s list runs to 9,260 characters. The first part is shown; the rest is on FDA’s record.
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 - US Nationwide and countries of Canada Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Chile China Colombia Czech Republic Denmark Egypt Finland France French Guiana Germany Guadeloupe Hong Kong Hungary India Indonesia Iran Israel Italy Japan Jordan Korea, Republic of Kuwait Kyrgyzstan Latvia Luxembourg Maldives Martinique Mexico Netherlands New Zealand Norway Panama Peru Poland Portugal Qatar Romania Russian Federation Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom
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 Sep 19, 2018.
- FDA classified it on Oct 24, 2018.
- FDA’s Enforcement Report published it on Oct 31, 2018.
- FDA terminated it on Aug 10, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips Medical Systems Gmbh, DMC, of Hamburg, Germany.
- 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.”
- FDA’s list of codes runs to 9,260 characters; the first part is shown here, and the rest is on FDA’s record.
- 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.