IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are tradi...

FDA Device Recall #Z-1645-2018 — Class II — April 4, 2018

Recall Summary

Recall Number Z-1645-2018
Classification Class II — Moderate risk
Date Initiated April 4, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Deerfield Imaging, Inc.
Location Minnetonka, MN
Product Type Devices
Quantity 10 units

Product Description

IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative inside an RF shielded room to facilitate intraoperative and multi room use.

Reason for Recall

The DC power to the IFOSS collision detector control panel at your facility is being adversely affected by the magnetic field. Our investigation shows the magnetic field is causing the IFOSS control panel to malfunction.

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of OH, FL, NH, TX, Sweden, Canada

Lot / Code Information

Serial Numbers: 10111-00, 10073-01, 10043-01, 10097-01, 10006-11, 10076-21, 10081-01, 10089-01, 10101-01, 10093-01

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-2584-2021 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

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.