Achilles Express Bone Sonometer
Check against the official notice below — it lists the full affected range.
GE Healthcare, LLC is recalling 241 Achilles Express and Achilles Insight bone sonometer systems that were shipped with incorrect European CEE-7/7 Type Power Cords to countries requiring three protruding pin plugs for proper protective earth connection. The affected devices were distributed nationwide to Arizona, Georgia, Montana, North Carolina, New Jersey, New York, Ohio, and Wisconsin, as well as internationally to numerous countries including Australia, Brazil, China, India, Mexico, and the United Arab Emirates.
The recall affects specific system models identified by their System IDs and serial numbers. The record does not specify a remedy for consumers with affected devices.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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: 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 Emirate Quantity: 241 devices Lot/code info: 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, 830
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.