Head fixation devices recalled because a torque screw may crack or separate
IMRIS Imaging is recalling 122 HFD100 Head Fixation Devices because a torque screw may crack or separate, which could lead to inadequate head stabilization and risk of patient injury.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states a cracked screw could compromise head stabilization and risk patient injury, and no injuries are reported.
Plain-English summary
The HFD100 Head Fixation Device is being recalled by IMRIS Imaging Inc, across catalog numbers including 119695-000, 119629-000, 119630-000, 113803-000 and 113802-000.
The record states that a torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.
The record lists 122 units, with affected UDI-DIs including 00857534006011, 00857534006592, 00857534006608 and 00857534006615, and affected serial numbers listed in the enforcement record. Distribution was worldwide, including nationwide in the United States and to Canada, Sweden, Switzerland, Japan, Australia and Qatar among other countries. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should quarantine affected stock and follow the firm's instructions.
The recalled product
- Product
- Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The HFD100 Head Fixation Device provides rigid skeletal
- Manufacturer
- IMRIS Imaging Inc
- Hazard
- screw-failure
- head-fixation
- surgical-precision
- patient-injury-risk
Distribution
Distributed nationwide across the United States.
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