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U.S. Department of Health and Human Services

Class 2 Device Recall Elekta VBH Head FIX

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 Class 2 Device Recall Elekta VBH Head FIXsee related information
Date Initiated by FirmOctober 14, 2010
Date PostedDecember 03, 2010
Recall Status1 Terminated 3 on December 28, 2010
Recall NumberZ-0538-2011
Recall Event ID 57111
510(K)NumberK030439 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductElekta 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.
Code Information P10103
FEI Number 1037831
Recalling Firm/
Manufacturer		 Elekta, Inc.
4775 Peachtree Industrial Blvd
Bldg 300, #300
Norcross GA 30092-3011
For Additional Information ContactThomas Valentine
770-300-9725
Manufacturer 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 Determined
Cause 2		Other
ActionElekta, 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 service.schwabmuenchen@elekta.com
Quantity in Commerce34 units
DistributionWorldwide 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IYE
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