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Recall Observatory FDA recall evidence

Device product

Achilles Insight Bone Sonometer

Z-0112-2020

September 03, 2019

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 83811
Status
Terminated
Classification
Class II
Quantity
599 devices
Official record key
device-enforcement:Z-0112-2020

Official wording

Reason: Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth connection.

Code information: System ID: AWI33021, AWI33682, 0911LN0007, 091133NZM31481, 091133NZM31582, 091133NZM31875, BH1055US01, 0002860952, 0002868705, 83033603652009, 83033604564999, 0002657156, ACH+12941, ACH+12946, 084733NZM31677, 2644078, 82433040028, 82433040037, 82433070008, 82433120015, 82433080005, 82433040035, 82433040039, 82433140020, 82433290005, 82433130044, 82433130045, 82433230011, 82433140022, 82433140023, 82433140021, 82433140016, 0002556007X, CY1121US01, 828330064, 828330102, 828330049, 828330082, 83033005100157, 0002752556, 83033825104417, 83033205101815, 83033209010045, IQ1287US02, IQ1084US01, IE1016LU04, IE1063LU02, IE1106LU02, IE1106LU03, IE1153US01, IE1131US01, A6165801, A185446001, A6141901, A5945702, B5313202, A6141801, A5807032, A167409101, A6089201, A156115001, A6091501, B5481117, A5314930, B5715201, B5715202, A6143401, A6082001, B120559406, A6141601, A5997501, A5959302, C5120921, A5250606, A144165602, A6122001, A6124501, A6124502, A6110401, A147112602, A258018801, B5131818, A5968201, A130541401, A5380304, A5260003, B5767801, A130693801, A174758001, A140158101, A174051701, B5131817, A6095201, M5389201, L5389201, A5809709, A5958402, A118189801, A5806323, A5161606, A101031001, A146202101, B103443901, A5152967, A5715233, C5618310, A5715240, A5715241, A5715259, A5961502, A5725504, A5307201, N5389201, C5389202, B5495516, A119703501, A6165901, A6165902, A5811908, A5367101, A5178019, A5178029, A195945609, A5304827, A5353829, A6089301, A6089303, A6089304, A6089306, A6141701, A5483703, A5958003, A5983601, A6049301, A5977401, A258022001, A5985601, A5975602, A6096703, A5358111, A51142115, A238763702, A5990601, A6001902, A236506901, A236506902, A236506903, A236506905, A236506906, A236506907, A236506908, A258022401, A258022403, A258022404, A258022405, A258022406, A258022412, A258022416, A258022419, A258022421, A258022424, A258022428, A5715201, A5715262, A5715264, A5715267, A6032002, A6032003, A6086801, A5985201, B5381901, A5980802, A5980803, A5216510, A5141812, A176817401, A6082101, A128549801, A128549803, A128549804, A161284802, A176528801, A5217506, A5114898, A5287805, KW1111US01, LB1323US01, LB1149US02, 834334016, 834334005, 834334042, 834334068, 834374457, 834334008, 834334011, 834334012, 834334030, 834334033, 834334034, 834334047, 834334017, 834334048, 834334058, 834334060, 834334066, 834334067, 834334015, 834334018, 834334057, 834334043, 834334056, 834334059, 083433NZM31194, 083433NZM31201, 083433NZM31221, 083433NZM31223, 083433NZM31259, 083433NZM31262, 083433NZM31270, 083433NZM31275, 083433NZM31427, 083433NZM31496, 083433NZM31572, 083433NZM33053, 083433NZM33054, 083433NZM33055, 083433NZM33056, 083433NZM33057, 083433NZM33377, 083433NZM33378, MU1012US01, MU1012US02, MU1012US03, ACI31938, ACI31939, ACI31940, ACI31941, 2651516, 2738051, 085633NZM33272A, 085633NZM33349G, 085633NZM33499G, OM1068US01, 0002649897, 0002507221X, 0002508220X, 843334004, 843334008, 843334010, 843334011, 843334012, 843334013, 843334015, 843334028, 843334219, 843374239, 843334000, 843334001, 843334006, 843334026, 843334027, 084333NZM31192, 084333NZM31217, 084333NZM31245, 084333NZM31429, 084333NZM31461, 084333NZM31483, 084333NZM31860, 084333NZM31874, 084333NZM32908, 084333NZM32909, 084333NZM32910, 084333NZM32911, 084333NZM32912, 084333NZM32913, 084333NZM33062, 084333NZM33063, 084333NZM33064, 084333NZM33065, 084333NZM33066, 084333NZM33067, 084333NZM33244, 084333NZM33261, 084333NZM33262, 084333NZM33263, 084333NZM33265, 084333NZM33266, 084333NZM33269, 084333NZM33274, 084333NZM33277, 084333NZM33278, 084333NZM33279, 084333NZM33280, 084333NZM33281, 084333NZM33282, 084333NZM33284, 084333NZM33298, SA2344XR01, SA2198XR01, SA2200XR01, SA2250XR01, SA2250XR02, SA2195XR04, SA2251XR01, SA2251XR07, SA2251XR08, SA2251XR09, SA2251XR10, SA2196XR01, SA2137XR02, SA2137XR03, SA2137XR07, SA2137XR01, SA2146XR02, SA2205XR01, SA2081XR01, SA2082XR01, SA2083XR01, SA2106XR01, SA2106XR03, SA2109XR01, SA2109XR02, SA2109XR03, SA2106XR02, SA2106XR04, SA1011XR06, SA1381XR02, SA1381XR03, 847334000, 847334001, 847334053, 847334058, 847334073, 847334075, 847334076, 084733NZM31243, 084733NZM31266, 084733NZM31271, 084733NZM31462, 084733NZM31471, 084733NZM31472, 084733NZM31586, 084733NZM31863, 084733NZM31872, 084733NZM31878, 084733NZM33498, 084733NZM40110A, 847334054, 847334061, 847334071, 847334074, 83033602003711, 83033602003712, 83033602003713, 83033602003714, 83033805200659, 83033809427599, 479261BD01, 492049BD01, 612711BD01, 537615BD01, 615070BD01, 717010US02, 717010US03, 717010US07, 717010US08, 717010US09, 717010US11, 483657US01, 226529BD01, 932030BD02, 579811BD01, 853330046, 853330239, 853330180, 853330215, 853330320, 853330321, 853330322, 853330323, 853330324, 853330333, 853330334, 853330335, 853330336, 853330337, 853330338, 853330339, 853330340, 853330341, 853330342, 853330347, 853330348, 853330349, 853330350, 853330351, 853330352, 853330353, 853330354, 853330358, 853330359, 853330360, 853330376, 853330377, 853330378, 853330379, 853330380, 853330381, 853330382, 853330383, 853330384, 853330385, 853330386, 853330387, 853330388, 853330389, 853330390, 853330391, 853330392, 853330394, 853330395, 853330396, 853330397, 853330398, 853330399, 853330403, 853330404, 853330405, 0853330200B, 853330256, 853330181, 853330201, 853330064, 853330216, 853330223, 853330166, 853330192, 853330212, 853330235, 853330248, 853330240, 853330191, 853330024, 853330025, 853330035, 853330036, 853330037, 853330038, 853330040, 853330045, 853330047, 853330048, 853330069, 853330070, 853330071, 853330073, 853330075, 853330076, 853330077, 853330097, 853330107, 853330108, 853330137, 853330138, 853330139, 853330140, 853330141, 853330142, 853330143, 853330144, 853330148, 853330149, 853330150, 853330151, 853330152, 853330153, 853330167, 853330168, 853330169, 853330170, 853330171, 853330172, 853330179, 853330182, 853330183, 853330184, 853330185, 853330186, 853330187, 853330193, 853330194, 853330195, 853330196, 853330202, 853330210, 853330217, 853330218, 853330219, 0853330222D, 853330228, 853330229, 853330234, 853330236, 853330238, 853330241, 853330249, 853330250, 853330254, 853330255, 853330262, 853330263, 853330266, 853330267, 853330269, 853330270, 853330281, 853330282, 853330283, 853330284, 853330285, 853330287, 853330288, 853330290, 853330291, 853330292, 853330293, 853330294, 853330297, 853330298, 853330299, 853330300, 853330301, 853330309, 853330310, 853330311, 853330312, 856330022, 856330047, 856330075, 856330076, 856330077, 856330078, 856330079, 856330080, 856330081, 856330082, 856330093, 856330095, 856330018, 856330010, 856330011, 856330012, 856330023, 856330005, 856330021, 856330050, 856330051, 856330052, 856330053, 856330006, 856330071, 856330069, 856330056, 856330026, 856330070, 085633NZM31191, 085633NZM31203, 085633NZM31224, 085633NZM31260, 085633NZM31265, 856330055, 856330015, 856330094, 856330096, 856330001, 856330102, 856330057, AE1189XR01, AE1336XR01, AE1145XR01, AE1148XR01, AE1165XR01, AE1241XR01, AE1223XR01, AE1223XR02, AE1154XR01, AE1201XR01, AE1221XR01, AE1223XR03, AE1223XR11, AE1224XR01, AE1237XR01, AE1149XR03, AE1243XR01, 20505RAD01, 20246RAD01, 20146RAD03, 11235RAD01, 10919RAD01

Distribution pattern: Nationwide distribution to AZ, GA, MT, NC, NJ, NY, OH, WI. International distribution to Australia, Bahrain, Bangladesh, Brazil, Cambodia, Chile, China, Colombia, Cyprus, Hong Kong, India, Iraq, Ireland, Italy, Kuwait, Lebanon, Malaysia, Mauritius, Mexico, MEXICO, Myanmar, Nepal, Oman, Panama, Peru, Philippines, Saudi Arabia, Singapore, Sri Lanka, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uruguay, Vietnam

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth connection.