FDA · Medical device recall

Achilles Insight Bone Sonometer and 1 more product

Oct. 16, 2019 Class II

Date: Oct. 16, 2019
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Terminated
Filed by: GE Healthcare, LLC
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.
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

2 products in this recall

Achilles Insight Bone Sonometer

Product: Achilles Insight Bone Sonometer
Quantity: 599 devices
Codes and lots: 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
Recall started: Sept. 3, 2019
Device type: Bone Sonometer
Root cause (FDA): Device Design
What the company told customers: GE Healthcare notified customers on about 09/03/2019, via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were informed of two (2) safety issues. The first safety issue was that 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. This issue could lead to an electric shock. There have been no reported injuries as a result of this issue. Specific safety instructions included to continue using the system after following the below instructions: 1. Inspect the power cord set used on your Achilles Express or Achilles Insight system and ensure its compatibility with your wall socket; 2. Use the European CEE 7/7 Type plug only with the two wall sockets because the protective earthing connection will not be established with any other socket; 3. Do not use any adapters with your plug or wall socket; 4. If you have a CEE 7/7 Type plug and a wall socket other than that shown in Figure 2 of the letter, discontinue use of your system. Your power cord set will be replaced with the correct power cord. Destroy the incorrect power cord to ensure it is not used. The second safety issue is that certain Achilles Express and Achilles Insight systems were shipped with 125V rated power cords (type B plug) to these countries where the mains voltage could be greater than 200V. This issue could lead to an electric shock. There have been no reported injuries as a result of this issue. Specific safety instructions included, that for certain systems in Peru, Philippines and Thailand, a power cord type B plug rated at 125V, as shown in Figure 3, was shipped. The mains voltage in these countries could be greater than 200V and, as a result, this plug should not be used. If you are located in one of these three countries with mains voltage greater than 200V and have the plug shown in Figure 3 of the letter, disconnect your Achil
Recall number: Z-0112-2020

Achilles Express Bone Sonometer

Product: Achilles Express Bone Sonometer
Quantity: 241 devices
Codes and lots: System ID: ACE34924, AWE11358, ACE34606, ACE34652, ACE34651, AWE11894, AWE1196, ACE34927, ACE886H, AWE10447, AWE11047, AWE11098, AWE11304, AWE11312, AWE11317, AWE11381, AWE11285, ACH+12937, ACH+12932, ACH+12939, ACH+12935, ACH+12942, ACH+12936, ACH+12943, ACH+12938, ACH+12945, ACH+12940, ACH+12947, ACH+12952, ACH+12948, ACH+12871, ACH+12933, ACH+12872, ACH+12931, ACH+12290, ACH+12955, ACH+12975, ACH+12978, ACH+12983GA, ACH+12986, 2798401, 2815867, 2858452, 2876988, 2693419, 0002722584A, ACH10439, ACH31114, ACH10346, ACH10364, ACH10393, 828330086, 828330087,828330097, 828330098, 828330115, 828330091, 828330099, 828330119, 828330117, 83033100400411, 83033100024611, 83033000014510, 83033005000787, 83033004563599, 83033005000579, 83033005002887, 83033005003917, 83033000410110, 83033000415311, 83033004190909, 83033005000938, 83033005000978, 83033005002399, 83033009010429, 0002765007, 0002549803A, 83033000000018, 83033001234568, 83033009010046, 83033206010165, 83033209010165, 83033240415211, 83033245000577, 83033000011810, 0002830095, 0002960988, 0004225139, 0004241217, 83033820408610, 83033825000089, 83033825000098, 83033825000359, 83033825100325, 83033825101736, 83033826101736, 83033860068211, 83033200414211, 83033200012210, 83033200407710, 83033200407711, 83033200407712, 83033200413211, 83033205001468, 83033205105099, 83033205355099, 83033200012010, 83033200024711, 83033205104326, 83037200413111, 83033205002496, 83033205000068, 83033205004238, 83033605001326, 83033205102295, 83033209026036, 83033209026076, 0002540710, 0002767636, 0002767636A, 0002767636B, 0002767636C, 0002767636D, 83033005102305, 83033825000156, 83033205101507, 83033205101456, 83033205007588, 83033805004289, 83033205004228, 83033065000199, 83033205002037, 83033005105137, 83033806695010, 83033805001126, 0002790424, 83033600000008, 83033600308711, 83033605105157, IE1574LU01, A179802601, A258022402, 834334061, 834334010, 834334026, 834334028, 834334029, 834334004, 834334007, 834334006, 834334054, 834334055, 083433NZM30581, 083433NZM30585, 083433NZM30662, 83033008881210, 83033008881211, 0002501112B, 0002508220A, 0002791713, 0002818827, 0002732489, 0002739062, ACH+11056, 843334009, 084333NZM31123, 843334218, SA2155XR01, 847334059, 6073UL0164, 83033805200666, 853330027, 853330028, 853330029, 853330030, 853330031, 853330032, 853330033, 853330034, 853330057, 853330059, 853330060, 853330061, 853330062, 853330065, 853330072, 853330074, 853330080, 853330081, 853330082, 853330083, 853330084, 853330085, 856330003, 856330029, 856330002, 856330013, 856330019, 856330014, 856330016, 085633NZM10512, 085633NZM10524, 085633NZM11414, 085633NZM11693, 085633NZM12132, 085633NZM12134, 085633NZM12754, 085633NZM12755, 085633NZM12756, 856330009, 856330034, 856330007, 856330008, 856330004, 20181RAD02, 20181RAD03, 10423RAD02, 10423RAD03, 10423RAD04, 10423RAD05, 10423RAD06, 10423RAD07, 10423RAD08, 10423RAD09, 10423RAD10, 10423RAD11, 10423RAD12, 10423RAD13, 20356RAD03, 20357RAD01, 10422RAD02, 20355RAD02, 20109RAD02, 21001RAD01, 21008RAD01, 21008RAD02, 21008RAD03, 20358RAD01, 0002593515X, 0002638962, 859334009
Recall started: Sept. 3, 2019
Device type: Bone Sonometer
Root cause (FDA): Device Design
What the company told customers: GE Healthcare notified customers on about 09/03/2019, via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were informed of two (2) safety issues. The first safety issue was that 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. This issue could lead to an electric shock. There have been no reported injuries as a result of this issue. Specific safety instructions included to continue using the system after following the below instructions: 1. Inspect the power cord set used on your Achilles Express or Achilles Insight system and ensure its compatibility with your wall socket; 2. Use the European CEE 7/7 Type plug only with the two wall sockets because the protective earthing connection will not be established with any other socket; 3. Do not use any adapters with your plug or wall socket; 4. If you have a CEE 7/7 Type plug and a wall socket other than that shown in Figure 2 of the letter, discontinue use of your system. Your power cord set will be replaced with the correct power cord. Destroy the incorrect power cord to ensure it is not used. The second safety issue is that certain Achilles Express and Achilles Insight systems were shipped with 125V rated power cords (type B plug) to these countries where the mains voltage could be greater than 200V. This issue could lead to an electric shock. There have been no reported injuries as a result of this issue. Specific safety instructions included, that for certain systems in Peru, Philippines and Thailand, a power cord type B plug rated at 125V, as shown in Figure 3, was shipped. The mains voltage in these countries could be greater than 200V and, as a result, this plug should not be used. If you are located in one of these three countries with mains voltage greater than 200V and have the plug shown in Figure 3 of the letter, disconnect your Achil
Recall number: Z-0113-2020

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0112-2020, Z-0113-2020. The agency record governs; check it and the company before acting.

Report a mistake on this page