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-0729-2024
- 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 Multi-Specialty Echocardiography and Multi-Specialty with Electric Access Back Supports [left & right}
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): 00817463025422 S/N: USM839457 USM839458 USM839459 USM839460 USM839461 USM818212 USM833897 USW813999 USM839614 USM839615 USM814871 USM833507 USM831797 USM823858 USM822620 USM824500 USM834529 USM788091 USM815794 USM832170
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 93595| 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 |