IMRIS MR/X-ray head fixation device recall
IMRIS MR/X-ray head fixation device, Model HFD200
Why was IMRIS MR/X-ray head fixation device recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
HFD Serial Number Drive Knob Serial Number 10002481 10003305 10002351 10005723 10004247 10002448
- Product
- IMRIS MR/X-ray head fixation device, Model HFD200
- Recalling firm
- Deerfield Imaging, Inc.
- Quantity
- 3 units
- Distribution
- TN, NH, FL
- Recall date
- October 30, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)