Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended U...
FDA Device Recall #Z-2349-2021 — Class II — June 29, 2021
Recall Summary
| Recall Number | Z-2349-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 29, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Oakworks Inc |
| Location | New Freedom, PA |
| Product Type | Devices |
| Quantity | 55 units |
Product Description
Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound examination table Catalog Number: 66783 and 64219
Reason for Recall
Weld failure- the bracket attaches the tabletop tilting actuator to the tabletop frame. If the bracket weld fails, the tabletop tilting action is non-functional
Distribution Pattern
Nationwide
Lot / Code Information
Serial Number/Part Number VCF766794 USGNV22723723MTTZZCE2S; VCF767303 USGNV23023723MTTZZ2S; VCF771999 USGNV23023723MTTZZ2S; VCF774252 USGNV23023723MTTZZ2S; VCF776073 USGNV23023723MTTZZ2S; VCF776198 USGNV23023723MTTZZ2S; VCF778246 USGNV23023723MTTZZ2S; VCF778247 USGNV23023723MTTZZ2S; VCF779362 USGNV23023723MTTZZ2S; VCF780260 USGNV23023723MTTZZ2S; VCS781126 USGNV13023723MTTZZ2S; VCF783652 USGNV22723723MTTZZF82S; VCF783969 USGNV23023723MTTZZF82S; VCF785961 USGNV22723723MTTZZCE2S; VCS766698 USGNV12723723MTTZZF62S; VCF768278 USGNV23023723MTTZZCEDRMC2S; VCF770016 USGNV23023723MTTZZ2S; VCF770017 USGNV23023723MTTZZ2S; VCF770571 USGNV23023723MTTZZCE2S; VCF771782 USGNV23023723MTTZZF8MC2S; VCF776974 USGNV22723723MTTZZ2S; VCF778602 USGNV23023723MTTZZ2S; VCF779609 USGNV23023723MTTZZF8CE2S; VCF781198 USGNV23023723MTTZZ2S; VCF784255 USGNV23023723MTTZZCE2S; VCF785376 USGNV23023723MTTZZ2S; VCF785650 USGNV23023723MTTZZF8MC2S; VCF786137 USGNV23023723MTTZZ2S; VCF786173 USGNV23023723MTTZZCE2S; VCF771553 USGNV23023723MTTZZCEMC2S; VCF771554 USGNV23023723MTTZZCEMC2S; VCF785065 USGNV22723723MTTZZF8CEDRDL2S; VCF771992 USGNV23023723MTTZZF8DRDL2S; VCF771993 USGNV23023723MTTZZF8DRDL2S; VCF782916 USGNV23023723MTTZZF8DRDL2S; VCF772035 USGNV22723723MTTZZ2S; VCF777288 USGNV22723723MTTZZ2S; VCF779024 USGNV22723723MTTZZ2S; VCF779025 USGNV22723723MTTZZ2S; VCF779026 USGNV22723723MTTZZ2S; VCF780977 USGNV22723723MTTZZ2S; VCF785219 USGNV22723723MTTZZ2S; VCF771311 USGNV23023723MTTZZ2S; VCF785744 USGNV22723723MTTZZCE2S; VCS772698 USGNV12723723MTTZZ2S; VCF771236 USGNV22723723MTTZZF8CE2S; VCF775658 USGNV23023723MTTZZ2S; VCF776370 USGNV23023723MTTZZ2S; VCF792903 USGNV23023723MTTZZMC2S; VCF773748 USGNV23023723MTTZZF8MC2S; VCF773748 USGNV23023723MTTZZCE2S; VCF779429 USGNV23023723MTTZZF8CE2S; VCF779921 USGNV23023723MTTZZF82S; VCF783233 USGNV23023723MTTZZ2S; VCF786329 USGNV22723723MTTZZ2S;
Other Recalls from Oakworks Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0729-2024 | Class II | Ultrasound EA (Ergonomic Advantage) table versi... | Dec 5, 2023 |
| Z-0728-2024 | Class II | Ultrasound EA (Ergonomic Advantage) table versi... | Dec 5, 2023 |
| Z-0730-2024 | Class II | Ultrasound EA (Ergonomic Advantage) table versi... | Dec 5, 2023 |
| Z-0727-2024 | Class II | Ultrasound EA (Ergonomic Advantage) table versi... | Dec 5, 2023 |
| Z-1238-2022 | Class II | PX200 Emergency Relief Bed; Model No. PXEXEB362... | Apr 21, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.