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.
FDA Recall Z-0538-2011 · Posted 2010-12-03
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Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2010-10-14
Date Terminated2010-12-28
Product Quantity34 units
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.
Firm 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]
Root Cause
Other
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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