FDAFDA · Food and drugs·Recall number Z-1514-2014
HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation therapy.
Published May 7, 2014 · Recall initiated: April 17, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
If screws are not properly tightened with a torque wrench they may become loose over time.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Elekta, Inc.
- Distributor
- 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 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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