OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028
Medical device recall Z-2300-2018. 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
- 508 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-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028
508, 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: 506241 500046 521648 522220 520020 533314 533471 533530 535257 535118 535924 540860 539106 547017 547142 547348 550258 553235 556585 558404 553676 41446090 42036161 42383151 43180366 43680651 43721258…
Every code shown here, 1,998 characters
As-Maintained System Equipment Number: 506241 500046 521648 522220 520020 533314 533471 533530 535257 535118 535924 540860 539106 547017 547142 547348 550258 553235 556585 558404 553676 41446090 42036161 42383151 43180366 43680651 43721258 41444692 41445222 44650754 41445407 533112 541490 41955077 529685 529691 529684 529698 531893 529697 535941 529696 539264 546436 545873 539037 546528 546466 546455 545730 545598 539038 552988 551489 41455862 41444624 42065190 16846483 32253458 34036766 34179085 34968065 38562442 35122350 35127482 35016455 35145439 35112843 37601105 36664230 39524825 41681475 41827402 16724453 17005034 30533360 31497860 32026120 32205530 31595070 33426990 34135240 34819721 34819433 38632412 49595524 39740578 31605917 32310045 32008570 31954213 32749341 33426349 32865331 33827811 33827815 34087855 34087725 34079339 34793296 35569101 37097710 38745116 42863234 45071255 31595927 31555908 31596387 32413391 32677737 35412750 47712544 36699008 36875502 48055521 48392876 47996476 47839619 48393084 47880448 48063679 48043493 48042722 47987365 48025752 47928350 47892427 48061968 48042349 47856992 48061077 47844521 47926256 47839510 47877204 48040901 47962639 47947771 47896920 47897948 47955020 47923399 47847457 48050932 47987662 48018973 47875559 48045859 48004328 48047339 47961100 48019288 47851789 47844718 47912804 47998626 47887154 47996779 48000293 47871220 47871127 47933015 47893201 47840174 47852334 47867843 47895480 47965379 47920668 47934675 48061768 48334268 48049352 47865582 48063783 48029479 48029389 48005570 47846129 48043619 48023634 47837558 48174545 47958286 48040455 100026747 100033278 100041586 100041603 100061466 100063646 100084933 100093452 100093436 100102230 100109716 33402044 34233967 34463532 34987357 35189871 36843853 38744050 38328053 38743946 41690350 41399001 42570682 47799271 36214396 64514623 48157631 57418995 51110146 51110037 50887154 51092653 51025290 50908284 50885339 51110174 51030160 51025580 50970665 50961004 50970143…
FDA’s list runs to 4,158 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 4,158 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.