Ultrasound EA (Ergonomic Advantage) table versions
Medical device recall Z-0728-2024. 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
- 104 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; G3 (General 3 Section) Echocardiography -An Ultrasound examination table
104 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
(UDI): , 00817463025439 S/N: USW821950 USW821951 USM838906 USM838908 USM838909 USM838910 USM838911 USM838912 USW833604 USW803220 USW810646 USM802363 USM802364 USM802365 USM802366 USM802367 USM802368 USM802369 USM802370 USM802371 USM802372…
Every code shown here, 1,068 characters
(UDI): , 00817463025439 S/N: USW821950 USW821951 USM838906 USM838908 USM838909 USM838910 USM838911 USM838912 USW833604 USW803220 USW810646 USM802363 USM802364 USM802365 USM802366 USM802367 USM802368 USM802369 USM802370 USM802371 USM802372 USM802373 USM806418 USM806419 USM824495 USW824575 USW824576 USW835742 USW835743 USW835744 USW835745 USW835870 USW835871 USW805335 USW805500 USW814481 USW814489 USW814490 USW814491 USM818829 USM818830 USW834435 USW834436 USW834437 USW834438 USW837136 USW837137 USW837138 USW837139 USW837140 USM834172 USW825108 USW836285 USW825254 USW825255 USW825256 USM832158 USM837032 USM805639 USM805640 USW809784 USW809785 USW810360 USM810619 USW811819 USW825625 USW825626 USW833747 USW806381 USW809243 USW810505 USM814053 USM814054 USM814055 USW829084 USW838113 USW838114 USW807763 USW800305 USM812019 USM812024 USM820560 USW832338 USM827491 USM805539 USM813172 USM813173 USM806277 USW817676 USW817677 USW818075 USW829140 USM809220 USM809200 USM809202 USM797137 USM819374 USM819375 USM819376 USM819377 USM819378 USM819379 USM819381 USM819382
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.”
- 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.