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
Couch, radiation therapy, powered - Product Code JAI
원인
If screws are not properly tightened with a torque wrench they may become loose over time.
조치
Corrective Action #1 - Important Field Safety Notice 618 01 302 002 was issued April 2014. The Notice informs end users about the problem and the potential clinical impact. It also give a recommendation how the risk can be mitigated - inspect the screws and if loose contact Elekta Service to tighten the screws with 20 Nm. The notice also advises the customer that a modification kit will be released that introduces an improved screw solution. The solution will be implemented on all affected products when available. Corrective Action #2 Permanent Solution - Replace Current Screws - An improved screw has been designed and will be available for Elekta Field Service organization to replace on all affected products at the end of April. The new design solution provides a very long used thread depth, exceeding the standard recommended thread-depths by far. This design will prevent the screws from loosening.
Worldwide Distribution-USA including DC and the states of AZ, CA, CT, FL, GA, IL, HI, KY, MD, MA, MI, MS, MO, NJ, NY, NH, NC, ND, OH, OK, OR, PA, SC, TX, VA, WA, WI, and WY, and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Kazakhstan, Mexico, Netherlands, New Zealand, Peru, Poland, Portugal, Russia, Saudi Arabia, South Korea, Span, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.
제품 설명
HexaPOD evo RT Couchtop. || To support and aid in positioning a patient during radiation therapy.