FDA Enforcement Class II Terminated

Medical Linear Accelerator

Recall: Z-2721-2016 · Reported September 14, 2016

Enforcement

Recall Number: Z-2721-2016
Event ID: 75052
Classification: Class II
Status: Terminated
Product Type: Devices
Firm: Elekta, Inc.
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: September 14, 2016
Initiation Date: July 8, 2016
Classification Date: September 2, 2016
Termination Date: November 24, 2017
Address: 400 Perimeter Center Ter NE Ste 50, Atlanta, GA, 30346-1227, United States

Description

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.

Code Info

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Distribution

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

Quantity

553