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Terminated

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

FDA Recall Z-1514-2014 · Posted 2014-04-25

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeJAI
Date Initiated2014-04-17
Date Terminated2015-01-29
Product Quantity266

Reason for Recall

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

Firm Action

Corrective Action #1 - Important Field Safety Notice 618 01 302 002 was issued April 2014. The Notice informs end users about the problem and the potential clinical impact. It also give a recommendation how the risk can be mitigated - inspect the screws and if loose contact Elekta Service to tighten the screws with 20 Nm. The notice also advises the customer that a modification kit will be released that introduces an improved screw solution. The solution will be implemented on all affected products when available. Corrective Action #2 Permanent Solution - Replace Current Screws - An improved screw has been designed and will be available for Elekta Field Service organization to replace on all affected products at the end of April. The new design solution provides a very long used thread depth, exceeding the standard recommended thread-depths by far. This design will prevent the screws from loosening.

Root Cause

Component design/selection

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072898HEXAPOD EVO RT COUCH TOPMedical Intelligence Medizintechnik GmbH · 2007-10-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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