CLASS II ONGOING Device recall · Reported 24 Jan 2024 · FDA Enforcement Report
Ultrasound EA (Ergonomic Advantage) table versions recalled by Oakworks
Oakworks is recalling Ultrasound EA (Ergonomic Advantage) table versions, distributed nationwide in the US. The recall was initiated on 5 Dec 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0728-2024
- FDA event ID
- 93595
- Recalling firm
- Oakworks, New Freedom, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Dec 2023
- FDA classified
- 12 Jan 2024
- Reported
- 24 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 5 Dec 2023 | Recall initiated by company | |
| 12 Jan 2024 | Classified by FDA | +38 days |
| 24 Jan 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Backrest platform stress fracture - the table is not operational in an inclined position
Product as listed by the FDA
Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
Backrest platform stress fracture - the table is not operational in an inclined position
Which lots are affected?
(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
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 93595This product is part of a recall event; the main page for the event is Ultrasound EA (Ergonomic Advantage) table versions recalled by Oakworks.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ultrasound EA (Ergonomic Advantage) table versions recalled by Oakworks | Oakworks | Other | Nationwide | |
| CLASS II | Ultrasound EA (Ergonomic Advantage) table recalled by Oakworks | Oakworks | Other | Nationwide | |
| CLASS II | Ultrasound EA (Ergonomic Advantage) table versions recalled by Oakworks | Oakworks | Other | Nationwide |
More recalls from Oakworks
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Ultrasound EA (Ergonomic Advantage) table versions recalled by Oakworks | Oakworks | Other | Nationwide |
| Device | CLASS II | Ultrasound EA (Ergonomic Advantage) table recalled by Oakworks | Oakworks | Other | Nationwide |
| Device | CLASS II | Ultrasound EA (Ergonomic Advantage) table versions recalled by Oakworks | Oakworks | Other | Nationwide |
| Device | CLASS II | Bed (Emergency Field Bed) recalled by Oakworks | Oakworks | Other | Nationwide |
| Device | CLASS II | PX200 Emergency Relief Bed recalled by Oakworks | Oakworks | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled | Canon Medical System USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay |