Recall Z-0163-2020— Deerfield Imaging, Inc.
Class II · Terminated
Class II FDA medical device recall by Deerfield Imaging, Inc., initiated 2019-06-26, terminated 2020-10-29. It names one FDA 510(k) clearance: K113748. Product: IMRIS MR/X-ray head fixation device, Model HFD200. Reason: 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..
- Recalling firm
- Deerfield Imaging, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-06-26
- Terminated
- 2020-10-29
- Firm location
- Minnetonka, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
IMRIS MR/X-ray head fixation device, Model HFD200
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.