U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Accelerator, linear, medical - Product Code IYE
원인
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.
조치
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
service.schwabmuenchen@elekta.com
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
제품 설명
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.