FDA Devices Moderate Class II Terminated

Medical Linear Accelerator

Reported: September 14, 2016 Initiated: July 8, 2016 #Z-2721-2016

Product Description

Reason for Recall

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.

Details

Recalling Firm: Elekta, Inc.
Units Affected: 553
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
Location: Atlanta, GA

Frequently Asked Questions

What product was recalled? ▼

Medical Linear Accelerator. Recalled by Elekta, Inc.. Units affected: 553.

Why was this product recalled? ▼

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.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on September 14, 2016. Severity: Moderate. Recall number: Z-2721-2016.