Varian Head Frame Posts Recalled Due to Rotation Risk
Varian Medical Systems is recalling 75 Head Frame Posts because they can rotate easily on the mounting cam. No serious injuries have been reported.
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 3/5 (High).
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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, which aligns with the High severity criteria in the rubric.
Plain-English summary
Varian Medical Systems, Inc. is recalling 75 units of the Varian Head Frame System, specifically the Head Frame Posts (PN1008016) and Post Kits. These devices are used with computed tomography scanners and charged particle accelerators for imaging and immobilization during stereotactic radiosurgery or radiotherapy treatments for cranial lesions and tumors.
The recall was initiated after a report indicated that the head frame posts could be easily rotated when attached to the mounting cam on the metal head ring. This mechanical instability poses a risk to patient immobilization during treatment. The source text explicitly states that there was no report of serious injury due to this issue.
The affected devices were distributed in the United States and internationally to one site each in Canada, India, and Morocco. Users of these devices should contact Varian Medical Systems for instructions on how to address the defect.
The recalled product
- Product
- Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform…
- Manufacturer
- Varian Medical Systems, Inc.
- Affected units
- 75
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Head Frame Posts and Post kits
Distribution
Distribution scope not specified by the agency.
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