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Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS...

FDA Device Recall #Z-0934-2022 — Class II — February 17, 2022

Recall Summary

Recall Number Z-0934-2022
Classification Class II — Moderate risk
Date Initiated February 17, 2022
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Deerfield Imaging, Inc.
Location Minnetonka, MN
Product Type Devices
Quantity 24

Product Description

Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and #119630-000, which are used with ORT400 operating room tables.

Reason for Recall

Reports have been received that after normal or routine lateral forces are applied to the head fixation device, the split block clamp may deflect (rotationally around the axis) and not return to within acceptable distance from its prior position after the force is removed. In order to reduce deflection at the table mount location, users have tightened the hand knob screw to a degree that it is then difficult to untighten it later in the clinical workflow. Rotational movement at the table attachment point could result in HFD movement going unnoticed, which could result in a situation where surgical or medical intervention is necessary, a situation where navigation needs to be reestablished, or a situation resulting in extended time under anesthesia for the patient. It may also be difficult to loosen the mount clamp component after use, potentially leading to ergonomic injury or a workaround during equipment teardown.

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of AL, FL, GA, MA, MN, NC, NY, OH, and TX. The countries of Sweden and Switzerland.

Lot / Code Information

Model #119629-000, UDI 00857534006592; and model #119630-000, UDI 00857534006615. Serial numbers: 10008164, 10007550, 10007555, 10008864, 10008160, 10008161, 10008859, 10008860, 10010668, 10010669, 10010673, 10010674, 10010672, 10007556, 10007557, 10008862, 10008861, 10008158, 10008159, 10008863, 10008165, 10007558, 10008865, and 10010675.

Other Recalls from Deerfield Imaging, Inc.

Recall # Classification Product Date
Z-2585-2021 Class II Operating room table - Product Usage: intended ... Aug 25, 2021
Z-2586-2021 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
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.

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