Z-0163-2020 Class II Terminated
FDA device recall Z-0163-2020 was initiated by Deerfield Imaging, Inc. on June 26, 2019 and is designated Class II. 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 recall status is terminated (terminated October 29, 2020). Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2019
- Initiation Date
- June 26, 2019
- Termination Date
- October 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
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.
Distribution Pattern
TN, NH, FL
Code Information
HFD Serial Number Drive Knob Serial Number 10002481 10003305 10002351 10005723 10004247 10002448