Ultrasound EA (Ergonomic Advantage) table versions
Medical device recall Z-0727-2024. Published in FDA’s Enforcement Report on Jan 24, 2024.
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 Jan 24, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 212 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?
Backrest platform stress fracture - the table is not operational in an inclined position
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound examination table
212 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
(UDI): 00817463025323 S/N: Serial Number USE837298 USE837299 USE832277 USE832279 USE812943 USE814317 USE799725 USE799726 USE799727 USE799730 USE799732 USE802575 USE802576 USE811024 USE811257 USE811258 USE811259 USE811260 USE811261…
Every code shown here, 1,991 characters
(UDI): 00817463025323 S/N: Serial Number USE837298 USE837299 USE832277 USE832279 USE812943 USE814317 USE799725 USE799726 USE799727 USE799730 USE799732 USE802575 USE802576 USE811024 USE811257 USE811258 USE811259 USE811260 USE811261 USE812704 USE813219 USE813603 USE818072 USE819626 USE824702 USE825956 USE825957 USE825958 USE825959 USE825960 USE826294 USE829080 USE829705 USE829706 USE829707 USE829708 USE829709 USE829710 USE832003 USE832004 USE832005 USE832006 USE832007 USE834846 USE835241 USE835242 USE835476 USE835776 USE836792 USE836879 USE836880 USE836881 USE836882 USE813594 USE813595 USE817820 USE839073 USE839074 USE839075 USE839076 USE814826 USE814827 USE814828 USE814829 USE814830 USE827308 USE803256 USE803299 USE803300 USE805960 USE805961 USE805962 USE809599 USE812579 USE815868 USE815908 USE817060 USE817061 USE818707 USE822030 USE824612 USE826254 USE828213 USE828214 USE829403 USE832116 USE832990 USE833712 USE833713 USE833960 USE838977 USE838254 USE805081 USE805082 USE818815 USE806583 USE811236 USE818243 USE819259 USE825037 USE835200 USE818139 USE818140 USE835527 USE835528 USE809360 USE811590 USE801767 USE805493 USE805494 USE805495 USE805794 USE805795 USE806093 USE806343 USE806782 USE806783 USE806784 USE807732 USE807827 USE807828 USE807832 USE807833 USE807834 USE807835 USE807836 USE807837 USE808960 USE808961 USE808962 USE809182 USE809631 USE809632 USE810336 USE810546 USE813715 USE813912 USE813913 USE813914 USE814416 USE814417 USE814418 USE816892 USE817024 USE817174 USE817457 USE817675 USE819750 USE822988 USE822989 USE823802 USE831280 USE831313 USE832776 USE834440 USE834875 USE834876 USE835877 USE836209 USE838838 USE838920 USE813405 USE805279 USE805280 USE805281 USE809749 USE809750 USE809751 USE809752 USE812563 USE812564 USE812565 USE812566 USE814568 USE817617 USE820048 USE833660 USE834269 USE835798 USE835799 USE835800 USE835801 USE835802 USE835803 USE835804 USE830284 USE811539 USE812084 USE816038 USE803752 USE801427 USE803589 USE839292 USE813104 USE813719…
FDA’s list runs to 2,160 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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 5, 2023.
- FDA classified it on Jan 12, 2024.
- FDA’s Enforcement Report published it on Jan 24, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Oakworks Inc, of New Freedom, PA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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 2,160 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
-
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.