CLASS II Device recall · Reported 14 Sep 2016 · FDA Enforcement Report

Medical Linear Accelerator recalled by Elekta

Elekta is recalling Medical Linear Accelerator, distributed in 20 states. The recall was initiated on 8 Jul 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes105639, 105652, 105608, 151187, 151401, 105792, 105570, 151577, 151563, 151562, 151444, 151347, 151746, 105557, 151434, 105801, 151702, 151052, 151384, 151661, 105873, 151138, 105875, 151606, 151246, 151649, 105729, 151642, 105820, 151097, 151063, 105857, 105952, 151227, 151208, 105935, 151345, 151120, 151057, 151018, 105684, 151122, 105573, 105973, 105688, 105768, 151078, 105908, 151039, 151323, 105953, 151607, 151023, 151164, 151304, 105569, 105900, 151070, 151293, 151548, 151631, 151618, 151609, 151547, 151105, 105994, 151437, 151124, 105597, 105839, 105947, 105753, 151205, 151240, 151239, 151382, 105779, 151490, 105732, 151270, 151648, 151232, 151440, 151307, 151408, 105552, 151485, 105746, 105745, 151276, 105889, 151147, 151056, 151294, 105830, 151592, 151286, 151282, 151118, 151381, 151375, 151376, 151400, 151593, 151508, 151589, 151590, 151637, 151726, 151721, 151707, 151750, 151742, 105897, 151342, 151069, 151019, 151163, 105747, 151407, 151182, 151081, 151646, 151113, 105605, 151106, 151242, 151337, 151641, 105917, 105899, 151564, 151591, 151021, 151535, 105933, 151290, 105985, 151068, 151343, 151027, 151732, 151218, 151219, 151220, 105735, 151554, 151192, 105834, 105752, 105642, 105599, 151191, 105674, 151645, 151131, 151111, 151277, 105993, 105634, 105919, 105848, 105620, 105579, 151402, 151193, 105740, 105613, 151257, 105901, 151283, 151355, 151635, 151202, 105877, 105756, 151221, 151518, 151575, 105592, 105733, 105965, 105940, 151139, 151409, 151204, 151230, 151559, 151146, 151152, 105824, 105662, 105651, 105730, 105623, 105686, 151758, 105670, 151261, 151048, 151279, 105931, 105631, 151665, 151126, 151426, 151037, 151036, 151513, 151738, 151543, 151339, 105689, 151753, 151174, 151745, 105755, 151473, 151241, 105737, 105999, 105920, 151668, 151013, 151336, 105817, 105804, 151603, 151395, 105748, 105996, 151536, 151172, 151392, 151100, 151210, 151161, 105680, 151263, 151058, 151028, 105842, 151417, 151331, 151109, 105743, 105742, 105635, 151004, 105802, 105797, 105786, 105695, 151478, 105906, 105904, 151527, 151487, 151486, 151415, 151414, 105813, 151413, 105720, 151188, 105781, 151032, 105638, 105957, 105789, 105769, 105814, 105874, 151692, 105595, 105583, 105581, 105850, 105607, 151475, 151688, 105554, 105923, 105980, 105867, 151731, 151614, 151615, 105991, 151123, 151350, 151484, 151389, 105677, 151034, 151464, 105976, 105641, 151499, 151166, 151133, 105683, 151082, 105807, 151041, 151452, 151740, 151195, 151031, 105934, 105835, 151271, 105946, 105602, 151088, 151087, 151720, 151206, 151622, 151621, 151102, 105778, 105763, 105574, 105852, 151060, 105791, 105679, 105663, 105702, 105701, 105681, 151199, 151061, 151209, 151660, 105825, 105622, 105983, 151324, 105572, 105767, 151505, 105643, 151427, 105938, 105562, 105808, 105885, 105893, 105892, 105628, 105589, 151274, 151273, 105687, 105603, 105939, 105878, 151667, 105997, 105711, 105903, 105765, 151525, 105780, 105833, 151150, 151730, 151357, 151506, 105978, 151117, 105966, 151551, 151561, 105849, 151234, 151265, 151287, 151252, 151203, 151280, 151468, 151619, 151761, 105862, 151747, 151272, 151681, 105795, 151565, 105669, 105799, 151064, 151108, 151235, 151103, 151302, 151459, 151448, 105715, 151226, 105749, 151741, 105986, 151476, 151555, 151716, 151715, 151310, 151315, 105937, 105758, 105927, 151101, 105915, 151224, 151213, 105661, 151017, 151000, 151040, 151299, 105975, 105974, 105943, 151171, 151005, 105948, 105615, 105863, 105860, 151713, 151520, 151712, 105783, 105712, 151454, 105964, 151671, 151438, 151007, 151534, 105640, 105861, 105869, 105703, 151233, 151066, 151237, 151121, 151669, 151135, 151119, 151542, 151509, 151451, 151181, 151011, 151010, 151533, 151532, 151356, 151329, 151544, 151733, 151725, 151262, 105762, 105951, 151142, 105972, 105764, 151071, 105576, 105930, 151137, 151541, 151089, 105777, 151085, 105575, 105866, 151165, 151179, 105782, 105881, 105646, 151008, 151167, 105844, 105829, 151154, 151099, 151098, 151029, 105886, 151695, 105754, 151266, 151134, 151305, 105593, 105837, 151537, 151016, 105969, 151238, 105883, 105563, 105666, 151421, 105744, 151228, 105929, 105564, 105894, 105895, 105846, 105624, 105841, 151325, 105568, 105660, 105806, 151422, 105960, 105925, 105949, 105898, 105699, 105872, 151229, 105864, 105678, 151093, 105759, 151320, 151456, 151457, 151639, 151687, 151148, 151373, 151149, 151321, 151374, 151322, 105847, 151549, 151365, 151083

Quantity recalled553

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2721-2016
FDA event ID: 75052
Recalling firm: Elekta, Atlanta, GA
Classification: Class II
Status: Terminated
Recall initiated: 8 Jul 2016
FDA classified: 2 Sep 2016
Reported: 14 Sep 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

8 Jul 2016	Recall initiated by company
2 Sep 2016	Classified by FDA	+56 days
14 Sep 2016	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There have been instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Medical Linear Accelerator

Where it was distributed

AL, AZ, CA, FL, GA, KY, MI, MN, MO, NE, NJ, NY, NC, OH, OK, PA, SC, TX, WA, WV, Argentina, Austria, Australia, Bosnia and Herzegovinia, Bangladesh, Belgium, Bulgaria, Brazil, China, Columbia, Cuba, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Iran, Italy, Japan, Jordan, Lebanon, Libya, Morocco, Mexico, Nigeria, Netherlands, Norway, Pakistan, Panama, Peru, Philippines, Portugal, Serbia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Syria, Taiwan, Thailand, Turkey, United Kingdom, Venezuela, Vietnam, Yemen

Alabama Arizona California Florida Georgia Kentucky Michigan Minnesota Missouri North Carolina Nebraska New Jersey New York Ohio Oklahoma Pennsylvania South Carolina Texas Washington West Virginia

Questions about this recall

Is Medical Linear Accelerator recalled?

Yes. Elekta recalled Medical Linear Accelerator on 8 Jul 2016. The recall is Class II and its status is Terminated. Recall number Z-2721-2016.

Why was it recalled?

There have been instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.

Which lots are affected?

105639, 105652, 105608, 151187, 151401, 105792, 105570, 151577, 151563, 151562, 151444, 151347, 151746, 105557, 151434, 105801, 151702, 151052, 151384, 151661, 105873, 151138, 105875, 151606, 151246, 151649, 105729, 151642, 105820, 151097, 151063, 105857, 105952, 151227, 151208, 105935, 151345, 151120, 151057, 151018, 105684, 151122, 105573, 105973, 105688, 105768, 151078, 105908, 151039, 151323, 105953, 151607, 151023, 151164, 151304, 105569, 105900, 151070, 151293, 151548, 151631, 151618, 151609, 151547, 151105, 105994, 151437, 151124, 105597, 105839, 105947, 105753, 151205, 151240, 151239, 151382, 105779, 151490, 105732, 151270, 151648, 151232, 151440, 151307, 151408, 105552, 151485, 105746, 105745, 151276, 105889, 151147, 151056, 151294, 105830, 151592, 151286, 151282, 151118, 151381, 151375, 151376, 151400, 151593, 151508, 151589, 151590, 151637, 151726, 151721, 151707, 151750, 151742, 105897, 151342, 151069, 151019, 151163, 105747, 151407, 151182, 151081, 151646, 151113, 105605, 151106, 151242, 151337, 151641, 105917, 105899, 151564, 151591, 151021, 151535, 105933, 151290, 105985, 151068, 151343, 151027, 151732, 151218, 151219, 151220, 105735, 151554, 151192, 105834, 105752, 105642, 105599, 151191, 105674, 151645, 151131, 151111, 151277, 105993, 105634, 105919, 105848, 105620, 105579, 151402, 151193, 105740, 105613, 151257, 105901, 151283, 151355, 151635, 151202, 105877, 105756, 151221, 151518, 151575, 105592, 105733, 105965, 105940, 151139, 151409, 151204, 151230, 151559, 151146, 151152, 105824, 105662, 105651, 105730, 105623, 105686, 151758, 105670, 151261, 151048, 151279, 105931, 105631, 151665, 151126, 151426, 151037, 151036, 151513, 151738, 151543, 151339, 105689, 151753, 151174, 151745, 105755, 151473, 151241, 105737, 105999, 105920, 151668, 151013, 151336, 105817, 105804, 151603, 151395, 105748, 105996, 151536, 151172, 151392, 151100, 151210, 151161, 105680, 151263, 151058, 151028, 105842, 151417, 151331, 151109, 105743, 105742, 105635, 151004, 105802, 105797, 105786, 105695, 151478, 105906, 105904, 151527, 151487, 151486, 151415, 151414, 105813, 151413, 105720, 151188, 105781, 151032, 105638, 105957, 105789, 105769, 105814, 105874, 151692, 105595, 105583, 105581, 105850, 105607, 151475, 151688, 105554, 105923, 105980, 105867, 151731, 151614, 151615, 105991, 151123, 151350, 151484, 151389, 105677, 151034, 151464, 105976, 105641, 151499, 151166, 151133, 105683, 151082, 105807, 151041, 151452, 151740, 151195, 151031, 105934, 105835, 151271, 105946, 105602, 151088, 151087, 151720, 151206, 151622, 151621, 151102, 105778, 105763, 105574, 105852, 151060, 105791, 105679, 105663, 105702, 105701, 105681, 151199, 151061, 151209, 151660, 105825, 105622, 105983, 151324, 105572, 105767, 151505, 105643, 151427, 105938, 105562, 105808, 105885, 105893, 105892, 105628, 105589, 151274, 151273, 105687, 105603, 105939, 105878, 151667, 105997, 105711, 105903, 105765, 151525, 105780, 105833, 151150, 151730, 151357, 151506, 105978, 151117, 105966, 151551, 151561, 105849, 151234, 151265, 151287, 151252, 151203, 151280, 151468, 151619, 151761, 105862, 151747, 151272, 151681, 105795, 151565, 105669, 105799, 151064, 151108, 151235, 151103, 151302, 151459, 151448, 105715, 151226, 105749, 151741, 105986, 151476, 151555, 151716, 151715, 151310, 151315, 105937, 105758, 105927, 151101, 105915, 151224, 151213, 105661, 151017, 151000, 151040, 151299, 105975, 105974, 105943, 151171, 151005, 105948, 105615, 105863, 105860, 151713, 151520, 151712, 105783, 105712, 151454, 105964, 151671, 151438, 151007, 151534, 105640, 105861, 105869, 105703, 151233, 151066, 151237, 151121, 151669, 151135, 151119, 151542, 151509, 151451, 151181, 151011, 151010, 151533, 151532, 151356, 151329, 151544, 151733, 151725, 151262, 105762, 105951, 151142, 105972, 105764, 151071, 105576, 105930, 151137, 151541, 151089, 105777, 151085, 105575, 105866, 151165, 151179, 105782, 105881, 105646, 151008, 151167, 105844, 105829, 151154, 151099, 151098, 151029, 105886, 151695, 105754, 151266, 151134, 151305, 105593, 105837, 151537, 151016, 105969, 151238, 105883, 105563, 105666, 151421, 105744, 151228, 105929, 105564, 105894, 105895, 105846, 105624, 105841, 151325, 105568, 105660, 105806, 151422, 105960, 105925, 105949, 105898, 105699, 105872, 151229, 105864, 105678, 151093, 105759, 151320, 151456, 151457, 151639, 151687, 151148, 151373, 151149, 151321, 151374, 151322, 105847, 151549, 151365, 151083

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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