[Recalled] IMRIS MR/X-ray head fixation device, Model HFD200 — Breaking of the HFD200 Drive Knob force indicator due to over-torqueing of the… | FDA 2019-06-26

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Breaking of the HFD200 Drive Knob force indicator due to over-torqueing of the drive knob beyond the maximum allowable pinning force specification may result in the clinical staff unknowingly pinning the patient's skull with insufficient force; the clinical staff unknowingly pinning the patient's skull with excessive force; or the clinical staff identifying the issue and not being able to continue with the procedure.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Deerfield Imaging, Inc.

• IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600 — Class II
• 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. — Class II
• IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indi — Class II
• Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient. — Class II
• IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-600 — Class II
• IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient. — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.