RecallRadar

FDA Device recall Z-0112-2020

Achilles Insight Bone Sonometer

On 2019-10-16 the FDA classified a Class II recall of Achilles Insight Bone Sonometer by Ge Healthcare, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0112-2020
ClassificationClass II
Statusterminated
Initiated2019-09-03
Published2019-10-16
Last updated2026-09-13 11:55 UTC
CompanyGe Healthcare
DistributionUS

Product

Achilles Insight Bone Sonometer

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.

Identifiers

code_info
System ID: AWI33021, AWI33682, 0911LN0007, 091133NZM31481, 091133NZM31582, 091133NZM31875, BH1055US01, 0002860952, 0002…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,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0112-2020%22

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