Achilles Insight Bone Sonometer
Enforcement
- Recall Number
- Z-0112-2020
- Event ID
- 83811
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- GE Healthcare, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 16, 2019
- Initiation Date
- September 3, 2019
- Classification Date
- October 10, 2019
- Termination Date
- February 16, 2021
- Address
- 3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States
Description
Achilles Insight Bone Sonometer
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.
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
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
599 devices