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

FDA device recall Z-1514-2014 · posted 2014-04-25 · Terminated

Recall details

Recalling firm

Elekta, Inc.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

JAI

Quantity 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 Alger

Date initiated

2014-04-17

Date posted

2014-04-25

Date terminated

2015-01-29

Location

Atlanta, GA

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