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

Recall number

Z-1514-2014

Recalling firm

Elekta, Inc.

Product

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

Status

Terminated

Initiated

2014-04-17

Posted

2014-04-25

Terminated

2015-01-29

Reason

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

Root cause

Component design/selection

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.

Quantity

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.

Lot, serial or model codes

Serial Numbers 42188, 42246, 42106, 42153, 42107, 42068, 42012, 42013, 42062, 42009, 42224, 42126, 3005, 42222, 3019, 3000, 42058, 42059, 42057, 42187, 42129, 42159, 3022, 3017, 42189, 42213, 42202, 42212, 42004, 4220, 42113, 42178, 42216, 42207, 2982, 2986, 2991, 42102, 42000, 42032, 42145, 42174, 42008, 42048, 42064, 42070, 42074, 42084, 42115, 42134, 42118, 42152, 42137, 42146, 3008, 2987, 3010, 3018, 42069, 42036, 3029, 42162, 42139, 42011, 42007, 42173, 42109, 42193, 3006, 42053, 42015, 42105, 42124, 42085, 42065, 42094, 42198, 2998, 3003, 3033, 3024, 2980, 42121, 2999, 42027, 42061, 42075, 42079, 42214, 3020, 42192, 42247, 42202, 42155, 42025, 42021, 42127, 42151, 42239, 42033, 42035, 42089, 42204, 42200, 2995, 3030, 42266, 42197, 42077, 42001, 42037, 42147, 42186, 42016, 42028, 42029, 42050, 42042, 42054, 42047, 42051, 42055, 42049, 42262, 42080, 42076, 42063, 42103, 42087, 42117, 42083, 42166, 42101, 42227, 42150, 42156, 42163, 42179, 42180, 42140, 42165, 42157,42234, 42169, 42182, 42183, 42236, 42195, 42223, 42256, 42276, 42260, 42231, 42250, 42243, 42240, 42272, 42235, 42249, 42254, 42245, 42265, 42268, 42267, 42253, 42264, 2993, 2997, 3004, 3031, 3002, 42226, 42258, 42114, 42081, 42090, 42093, 42133, 42181, 42039, 42116, 3016, 29677, 42010, 42073, 42176, 42164, 42031, 3028, 42041, 42038, 42022, 42034, 42088, 42104, 2976, 2979, 2988, 3011, 3015, 3021, 3027, 42238, 42018, 42135, 42252, 42185, 42273, 42060, 42024, 42006, 42082, 42194, 42263, 42232, 42199, 42170, 42161, 42078, 42158, 2985, 2994, 42120, 3032, 42056, 2969, 3034, 2975, 2972, 2984, 42191, 42225, 42228, 42023, 42143, 42122, 42208, 42230, 42211, 42026, 42206, 42066, 42052, 42014, 42218, 42030, 42040, 42244, 42043, 42044, 42045, 42046, 42123, 42255, 42141, 42125, 42072, 42112, 42210, 42017, 420196, 42020, 42067, 42071, 42097, 42100, 42131, 42144, 42136, 42148, 42130, 42111, 42067, 42171, 42203, 4210, 42205, 42096, 42154, 42241, 42229, 2981, 2989, 2971, 2990, 3007, 3013, 2992, 2973, 2978, 30098, 2974, 3014, 3012, 3025, 2996, 3026, 42274

510(k) numbers

["K072898"]

PMA numbers

not on file

Product code

JAI

Firm FEI

1037831

Firm city

Atlanta

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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