Reason for Recall
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Recall NumberZ-1622-2026ClassificationClass IIIStatusOngoingCategorydeviceInitiated2025-09-05Reported2026-04-01DistributionUS Nationwide distribution.Code InfoModel No. 989605439241, 989605439242, 21381A; UDI: (01)00884838067547(21)B093BQ, (01)00884838067547(21)B0988T, (01)00884838067547(21)02P6MY, (01)00884838067547(21)039M2Q, (01)00884838067547(21)0319CQ, (01)00884838067547(21)B01639; Serial No. 02GXR0, B093BQ, B0988T, 02P6MY, 039M2Q, 0341YT, 0319CQ, 028NZW, 02H0L8, B01639, 039M2M.Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.