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Recall Observatory FDA recall evidence

Device product

Medical Linear Accelerator

Z-2721-2016

July 08, 2016

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 75052
Status
Terminated
Classification
Class II
Quantity
553
Official record key
device-enforcement:Z-2721-2016

Official wording

Reason: 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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Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.