PlainRecalls
FDA Devices Moderate Class II Terminated

HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation therapy.

Reported: May 7, 2014 Initiated: April 17, 2014 #Z-1514-2014

Product Description

HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation therapy.

Reason for Recall

If screws are not properly tightened with a torque wrench they may become loose over time.

Details

Recalling Firm
Elekta, Inc.
Units Affected
266
Distribution
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.
Location
Atlanta, GA

Frequently Asked Questions

What product was recalled?
HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation therapy.. Recalled by Elekta, Inc.. Units affected: 266.
Why was this product recalled?
If screws are not properly tightened with a torque wrench they may become loose over time.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 7, 2014. Severity: Moderate. Recall number: Z-1514-2014.