Device product
Achilles Express Bone Sonometer
Z-0113-2020
Product summary
- Event
- Event 83811
- Status
- Terminated
- Classification
- Class II
- Quantity
- 241 devices
- Official record key
device-enforcement:Z-0113-2020
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: 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
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
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.