OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025
Medical device recall Z-2301-2018. Published in FDA’s Enforcement Report on Jul 4, 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 Jul 4, 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
- 477 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?
The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and the table will start to rotate from 0 to + 90 /- 90 degree with high speed. This rotating movement can not be stopped by the user. This could potentially lead to the patient falling off the table. There is a risk of injury for the patient, user, or bystander.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025
477, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
As-Maintained System Equipment Number: 76596 38351 76948 50428 82655 13124 85163 250340 86549 87164 86977 86965 86340 1520 101154 1873 102164 102977 83871 83958 86113 104857 103052 103219 84850 86303 103055 103058 103218 104012 104934…
Every code shown here, 1,999 characters
As-Maintained System Equipment Number: 76596 38351 76948 50428 82655 13124 85163 250340 86549 87164 86977 86965 86340 1520 101154 1873 102164 102977 83871 83958 86113 104857 103052 103219 84850 86303 103055 103058 103218 104012 104934 104577 105324 504972 504297 104858 529688 527085 527086 527104 527090 527082 529687 527080 527087 529686 527091 527092 527089 527093 529705 527109 527088 527102 527107 527083 527084 529703 529699 529713 529706 529712 529690 529710 529709 529708 529707 14629273 15893969 35015270 35014092 35127787 34997249 15849132 15857294 158554 15841822 15858211 16231503 15831844 16409964 16802355 18055578 18560502 15857902 15858098 303148 15854028 17492237 17541021 31456486 17758213 17941166 19392346 19579758 19782801 18809817 19257910 31103760 19782331 19935548 30396410 32054303 30194039 30873909 37103066 34090526 31596158 10135906 10166050 10006064 16064 10138539 47843126 479951 47911693 47901391 47844078 47944782 48030899 478435 47891928 47912290 48005677 486819 47837945 484516 47884920 47859977 47923515 48059776 48050512 47884354 47850684 48149946 47872003 47938350 47943336 47898047 48060837 478948 50194622 48016151 48062720 47995620 479809 47999720 47844799 47900809 48017211 47882644 47908199 48020563 48026144 48030684 47890048 48055971 47894387 47943186 47937552 48062279 47884829 47872447 47937672 48078137 47913036 479468 47894218 47926963 47889912 47900468 479897 47893535 47893638 47989775 48025019 48066707 48076135 47905960 14430237 48036987 48034012 48018140 47845684 47924690 15314079 47871520 47947079 48023192 47867463 47942597 486893 48016769 47987041 47871768 47934458 47987152 48037814 48055063 48055336 47989269 47945064 47847747 48025542 47902864 47883970 47880733 48022528 48056372 48056424 48056474 47880372 47954220 47843577 47878837 47951539 48048118 47956370 48008155 47915670 47838516 47921591 48057153 48086181 47840577 483428 47937095 47846955 47897860 48019597 48078998 47994839 48019837 47932196 47889837 48055440 47876560 47937175…
FDA’s list runs to 3,629 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.
US nationwide distribution.
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.
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 May 1, 2018.
- FDA classified it on Jun 27, 2018.
- FDA’s Enforcement Report published it on Jul 4, 2018.
- FDA terminated it on Jun 8, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips Medical Systems Nederlands, of Best, Netherlands.
- 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 3,629 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.