Foot Controls impacted for the following devices: OAKWORKS¿ Medical CFPM 300 Imaging Table OA...

FDA Device Recall #Z-0703-2018 — Class II — July 31, 2017

Recall Summary

Recall Number Z-0703-2018
Classification Class II — Moderate risk
Date Initiated July 31, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Oakworks Inc
Location New Freedom, PA
Product Type Devices
Quantity 1,104

Product Description

Foot Controls impacted for the following devices: OAKWORKS¿ Medical CFPM 300 Imaging Table OAKWORKS¿ Medical CFPM 301 Imaging Table OAKWORKS¿ Medical CFPM 400 Imaging Table OAKWORKS¿ Medical CFPM 401 Imaging Table OAKWORKS¿ Medical CFPMB 301 Bariatric Imaging Table OAKWORKS¿ Medical CFUR 301 Urology Table OAKWORKS¿ Medical CFUR 401 Urology Table OAKWORKS¿ Medical CFLU 401 Lithotripsy/Urology Table

Reason for Recall

The foot control used on the OAKWORKS¿ Inc., CFPM300, CFPM301, CFPM400, CFPM401, CFPMB301, CFUR301, CFUR401 and CFLU401 Imaging Tables can become lodged under the base or under the column of the table.

Distribution Pattern

USA (nationwide) Distribution

Lot / Code Information

MODEL #(s): "CFPM 300 "CFPM 301 "CFPM 400 "CFPM 401 "CFPMB 301 "CFUR 301 "CFUR 401 "CFLU 401 CATALOG #(s): "75208-T01 and 75209-T01 "75211-T01 and 75212-T01 "75204-T01 and 75205-T01 "75206-T01 and 75207-T01 "75213-T01 "75214-T01 "75215-T01 "75216-T01

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.