Deerfield Imaging Recalls IMRIS Head Fixation Devices Due to Knob Failure
Deerfield Imaging is recalling three IMRIS MR/X-ray head fixation devices because a broken drive knob may cause incorrect skull pinning force.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device that could lead to significant injury (excessive or insufficient skull pinning force).
Plain-English summary
Deerfield Imaging, Inc. is recalling three units of the IMRIS MR/X-ray head fixation device, Model HFD200. The recall was initiated because the HFD200 Drive Knob force indicator may break if the drive knob is over-torqued beyond the maximum allowable pinning force specification.
This defect may result in clinical staff unknowingly pinning the patient's skull with insufficient force or excessive force. Alternatively, the clinical staff may identify the issue and be unable to continue with the procedure. The affected units were distributed in Tennessee, New Hampshire, and Florida.
The specific serial numbers for the affected HFD and Drive Knob units are 10002481/10003305, 10002351/10005723, and 10004247/10002448. Healthcare facilities should contact Deerfield Imaging, Inc. for further instructions regarding the recall.
The recalled product
- Product
- IMRIS MR/X-ray head fixation device, Model HFD200
- Manufacturer
- Deerfield Imaging, Inc.
- Affected units
- 3
Distribution
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