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U.S. Department of Health and Human Services

Class 2 Device Recall IMRIS MR/Xray head fixation device

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  Class 2 Device Recall IMRIS MR/Xray head fixation device see related information
Date Initiated by Firm June 26, 2019
Create Date October 18, 2019
Recall Status1 Terminated 3 on October 29, 2020
Recall Number Z-0163-2020
Recall Event ID 83278
510(K)Number K113748  
Product Classification Holder, Head, Neurosurgical (Skull Clamp) - Product Code HBL
Product IMRIS MR/X-ray head fixation device, Model HFD200
Code Information HFD Serial Number Drive Knob Serial Number  10002481 10003305 10002351 10005723 10004247 10002448 
Recalling Firm/
Manufacturer		 Deerfield Imaging, Inc.
5101 Shady Oak Rd S
Minnetonka MN 55343-4100
For Additional Information Contact customer support
866-475-0525
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action The firm disseminated a field safety notice on 06/26/2019 by letter. The notice explained the problem and requested that the consignee inspect the skull clamp prior to use and be aware that overtightening of the drive knob may result in failure. The drive knobs will be replaced with an updated design when available.
Quantity in Commerce 3 units
Distribution TN, NH, FL
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HBL and Original Applicant = IMRIS, INC.
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