Achilles Insight Bone Sonometer
Check against the official notice below — it lists the full affected range.
GE Healthcare recalled 599 Achilles Express and Achilles Insight bone sonometer systems that were shipped with incorrect European CEE-7/7 Type power cords. These devices were distributed to certain states nationwide (Arizona, Georgia, Montana, North Carolina, New Jersey, New York, Ohio, and Wisconsin) and to numerous countries internationally. The hazard is that the European power cords have two round pins, but the countries where these systems were shipped require three protruding pin plugs for proper protective earth connection, creating a potential safety issue with the electrical grounding.
The affected devices can be identified by their System ID codes, which are listed in the recall details. The recall document does not specify what remedy GE Healthcare is offering to consumers who have affected units.
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: 599 devices Lot/code info: 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, A548370
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.