Achilles Express Bone Sonometer recall
Achilles Express Bone Sonometer
Why was Achilles Express Bone Sonometer recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Achilles Express Bone Sonometer
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 241 devices
- Distribution
- 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
- Recall date
- October 16, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)