FDA recall Z-0163-2020

Product

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.

Distribution

TN, NH, FL

Key facts

Status

Terminated

Initiation date

2019-06-26

Report date

2019-10-30

Termination date

2020-10-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minnetonka, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0163-2020