Z-0538-2011

Elekta VBH Head FIX The VBH HeadFIX is intended for positioning and immobilization of the head and neck...

Name: Z-0538-2011 Elekta VBH Head FIX The VBH HeadFIX is intended for positioning and immobilization of the head and neck...
Creator: Elekta, Inc.
Published: 2010-10-14
License: https://open.fda.gov/license/

Elekta Limited / initiated 2010-10-14 / Terminated

FDA source

Elekta, Inc. began a recall of Elekta VBH Head FIX The VBH HeadFIX is intended for positioning and immobilization of the head and neck, stereotactic diagnostic localization and stereotactic... on 2010-10-14. The reason FDA records is "The HeadFIX Baseplate is not screwed down to the adapter to allow to compensate for roll and pitch with the HeadFIX leveling screws of the HeadFIX Baseplate". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0538-2011
Status: Terminated
Initiated: 2010-10-14
Posted: 2010-12-03
Terminated: 2010-12-28
Recalling firm: Elekta Limited
Product: Elekta VBH Head FIX The VBH HeadFIX is intended for positioning and immobilization of the head and neck, stereotactic diagnostic localization and stereotactic radiotherapy of cranial targets.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: The HeadFIX Baseplate is not screwed down to the adapter to allow to compensate for roll and pitch with the HeadFIX leveling screws of the HeadFIX Baseplate.
FDA root cause: Other
Action: Elekta, Inc. sent an Important Notice A343 dated October 14, 2010 to all affected consignees. The Notice identified the product, the problem, and the action to be taken by the consignees. Consignees were instructed constantly monitor the patient before and during the treatment. Check the patient's position after every patient movement (e.g. coughing). Advise all appropriate personnel of the content of the notice place a copy of the Notice In the Important Notice Section of the HeadFix User Manual P10103-108. For questions regarding this recall [email protected]
Quantity in commerce: 34 units
Distribution: Worldwide Distribution - USA including AZ, CA, CT, FL, GA, IL, KY, MI, MS, NY, NC, OK, OR, RI, TN, TX, VA, WA and the country of Canada
Product codes and lots: P10103

Product code IYE

K030439Class IIHeadfixMedical Intelligence Medizintechnik GmbH / cleared 2003-05-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)