Class 2 Device Recall HexaPOD evo RT Couchtop

• Date Initiated by Firm: April 17, 2014
• Date Posted: April 25, 2014
• Recall Status: Terminated on January 29, 2015
• Recall Number: Z-1514-2014
• Recall Event ID: 68088
• 510(K)Number: K072898
• Product Classification: Couch, radiation therapy, powered - Product Code JAI
• Product: HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation therapy.
• Code Information: 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
• Recalling Firm/ Manufacturer: Elekta, Inc.; 400 Perimeter Center Ter Ne; Ste 50; Atlanta GA 30346-1227
• For Additional Information Contact: Linda Wetsel; 770-300-9725
• Manufacturer Reason for Recall: If screws are not properly tightened with a torque wrench they may become loose over time.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JAI