Elekta, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2721-2016)

Medical Linear Accelerator

Class II

There have been instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.

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AL, AZ, CA, FL, GA, KY, MI, MN, MO, NE, NJ, NY, NC, OH, OK, PA, SC, TX, WA, WV, Argentina, Austria, Australia, Bosnia and Herzegovinia, Bangladesh, Belgium, Bulgaria, Brazil, China, Columbia, Cuba, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Iran, Italy, Japan, Jordan, Lebanon, Libya, Morocco, Mexico, Nigeria, Netherlands, Norway, Pakistan, Panama, Peru, Philippines, Portugal, Serbia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Syria, Taiwan, Thailand, Turkey, United Kingdom, Venezuela, Vietnam, Yemen

Voluntary: Firm initiated