openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 1
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 immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.
Varian Medical Systems has received a report that a user was able to easily rotate the head frame posts when attached to the mounting cam on the metal head ring. There was no report of serious injury due to this issue
These labels are deterministic app interpretations, not FDA categories.
Varian Medical Systems has received a report that a user was able to easily rotate the head frame posts when attached to the mounting cam on the metal head ring. There was no report of serious injury due to this issue
Code information
All Head Frame Posts and Post kits
Distribution pattern
US Distribution and Internationally to 1 site in Canada, India and Morocco