Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic...
FDA Device Recall #Z-2584-2021 — Class II — August 25, 2021
Recall Summary
| Recall Number | Z-2584-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 25, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Deerfield Imaging, Inc. |
| Location | Minnetonka, MN |
| Product Type | Devices |
| Quantity | 13 units |
Product Description
Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
Reason for Recall
ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
Distribution Pattern
Worldwide distribution - US Nationwide distribution FL, NH, TX, OH, CA, OR, UT, TN, NC and the countries of Canada, Australia, Sweden, Japan.
Lot / Code Information
UDI: 00857534006738 and 00857534006349 Model Number: 113821-000 (Serial Number: 10002220); Model Number: 113821-600 (Serial Numbers: 10002692, 10006152, 10006991, 10004513, 10006997, and 10003754); Model Number: 114148-000 (Serial Numbers: 10004463, 10006891, 10005189, 10005190, 10004327, and 10004997)
Other Recalls from Deerfield Imaging, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0934-2022 | Class II | Trumpf Mount Clamp Assembly (table adapter comp... | Feb 17, 2022 |
| Z-2586-2021 | Class II | Operating room table - Product Usage: intended ... | Aug 25, 2021 |
| Z-2585-2021 | Class II | Operating room table - Product Usage: intended ... | Aug 25, 2021 |
| Z-0762-2020 | Class II | iMRX MRI and Angiography System, part number 10... | Nov 26, 2019 |
| Z-0163-2020 | Class II | IMRIS MR/X-ray head fixation device, Model HFD200 | Jun 26, 2019 |
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.