Oakworks Inc: Ultrasound Examination Tables Recalled for Backrest Platform Stress Fractures

Agency Publication Date: January 13, 2024

Summary

Oakworks Inc. is recalling 364 Ultrasound Ergonomic Advantage (EA) examination tables, including G2, G3, and V2 versions, due to structural defects in the backrest platform. The backrest can develop stress fractures, which prevents the table from operating correctly when in an inclined position. This defect affects specifically identified serial numbers across various configurations like General, Echocardiography, Multi-Specialty, and Vascular models. Oakworks has initiated this voluntary recall to address the mechanical failure of the backrest support system.

Risk

The backrest platform can suffer a stress fracture, causing the table to fail while in an inclined position. This poses a risk of the backrest suddenly collapsing or becoming unstable during a medical examination, which could result in patient or operator injury.

What You Should Do

Locate the serial number and Universal Device Identifier (UDI) on your Oakworks Ultrasound EA table to determine if it is included in this recall.
For the G2 General table, check for UDI 00817463025323 and serial numbers such as USE837298, USE837299, or USE832277 (see product list for full range of 212 serial numbers).
For G3 Echocardiography tables, check for UDI 00817463025439 and serial numbers such as USW821950, USW821951, or USM838906 (see product list for full range of 104 serial numbers).
For G3 Multi-Specialty tables, check for UDI 00817463025422 and serial numbers such as USM839457 through USM839461 (see product list for full range of 20 serial numbers).
For V2 Vascular tables, check for UDI 00817463025521 and serial numbers such as VCF805597, VCF814488, or VCF814750 (see product list for full range of 28 serial numbers).
If your table is affected, do not use the backrest in an inclined position if any signs of stress or instability are present.
Contact your healthcare provider or Oakworks Inc. immediately at 923 E Wellspring Rd, New Freedom, PA 17349 for further instructions and information on the repair or replacement process.
For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer (Oakworks Inc) for further instructions and potential refund or repair options.

Affected Products

Product: Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2)

Model / REF:

G2 (GENERAL 2)

UPC Codes:

00817463025323

Lot Numbers:

Serial Numbers: 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, USE810378, USE810379, USE835126, USE838175, USE817021, USE839597, USE839598, USE818132, USE818133, USE818134, USE818135, USE818136, USE818137, USE818138, USE802125, USE826701, USE831873

Product: Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography

Model / REF:

G3 Echocardiography

UPC Codes:

00817463025439

Lot Numbers:

Serial Numbers: 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

Product: Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electric Access Back Supports

Model / REF:

G3 Multi-Specialty

UPC Codes:

00817463025422

Lot Numbers:

Serial Numbers: USM839457, USM839458, USM839459, USM839460, USM839461, USM818212, USM833897, USW813999, USM839614, USM839615, USM814871, USM833507, USM831797, USM823858, USM822620, USM824500, USM834529, USM788091, USM815794, USM832170

Product: Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography

Model / REF:

V2 (Vascular 2 Section)

UPC Codes:

00817463025521

Lot Numbers:

Serial Numbers: VCF805597, VCF814488, VCF814750, VCF817222, VCF817223, VCF817720, VCF817721, VCF823450, VCF825629, VCF825630, VCF833350, VCF813968, VCF817520, VCF826533, VCF822117, VCF824501, VCF824502, VCF824503, VCF824504, VCF815120, VCF814849, VCF835728

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93595

Status: Active

Manufacturer: Oakworks Inc

Sold By: Authorized Medical Device Distributors; Direct Sales

Manufactured In: United States

Units Affected: 4 products (212 units; 104 units; 20 units; 28 units)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Locate the serial number and Universal Device Identifier (UDI) on your Oakworks Ultrasound EA table to determine if it is included in this recall.

For the G2 General table, check for UDI 00817463025323 and serial numbers such as USE837298, USE837299, or USE832277 (see product list for full range of 212 serial numbers).

For G3 Echocardiography tables, check for UDI 00817463025439 and serial numbers such as USW821950, USW821951, or USM838906 (see product list for full range of 104 serial numbers).

For G3 Multi-Specialty tables, check for UDI 00817463025422 and serial numbers such as USM839457 through USM839461 (see product list for full range of 20 serial numbers).

For V2 Vascular tables, check for UDI 00817463025521 and serial numbers such as VCF805597, VCF814488, or VCF814750 (see product list for full range of 28 serial numbers).

If your table is affected, do not use the backrest in an inclined position if any signs of stress or instability are present.

Contact your healthcare provider or Oakworks Inc. immediately at 923 E Wellspring Rd, New Freedom, PA 17349 for further instructions and information on the repair or replacement process.

For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2)

Model / REF:

G2 (GENERAL 2)

UPC Codes:

00817463025323

Lot Numbers:

Product: Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography

Model / REF:

G3 Echocardiography

UPC Codes:

00817463025439

Lot Numbers:

Product: Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electric Access Back Supports

Model / REF:

G3 Multi-Specialty

UPC Codes:

00817463025422

Lot Numbers:

Product: Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography

Model / REF:

V2 (Vascular 2 Section)

UPC Codes:

00817463025521

Lot Numbers: