To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Reason for recall: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Distribution: US Nationwide distribution. Quantity: 171,322 units Lot/code info: Model No. 989605412042, 989605438541, 989605388071, 989605365003, 989605365001, 989605366331, 989605387852, 989605365004, 989605492481, 989605431531, 989605412072, 989606702251, 989605391092, 989605353303, 989605418552, 989605455171, 989605412041; UDI: (01)00884838061491(21)B2JTQ2, (01)00884838061507(21)B2KPHY, (01)00884838061613(21)B0TN11, (01)00884838061613(21)B0WPLV, (01)00884838061613(21)B0ZVFL, (01)00884838061613(21)B126WZ, (01)00884838061613(21)B13K7V, (01)00884838061613(21)B1434L, (01)00884838061613(21)B14QMX, (01)00884838061613(21)B16ZF8, (01)00884838061613(21)B17161, (01)00884838061613(21)B173X2, (01)00884838061613(21)B1743J, (01)00884838061613(21)B1811G, (01)00884838061613(21)B1C20X, (01)00884838061613(21)B1C5K5, (01)00884838061613(21)B1C764, (01)00884838061613(21)B1DT4H, (01)00884838061613(21)B1DXHY, (01)00884838061613(21)B1FDZ9, (01)00884838061613(21)B1K2G0, (01)00884838061613(21)B1K7F0, (01)00884838061613(21)B1LCZW, (01)00884838061613(21)B1LHJ3, (01)00884838061613(21)B1LHW3, (01)00884838061613(21)B1LNLZ, (01)00884838061613(21)B1LY8D, (01)00884838061613(21)B1LZW9, (01)00884838061613(21)B1M2VG, (01)00884838061613(21)B1M9J6, (01)00884838061613(21)B1M9QW, (01)00884838061613(21)B1M9QY, (01)00884838061613(21)B1M9RX, (01)00884838061613(21)B1MBPX, (01)00884838061613(21)B1MBQ3, (01)00884838061613(21)B1MKHL, (01)00884838061613(21)B1MKQM, (01)00884838061613(21)B1MKTB, (01)00884838061613(21)B1MKZF, (01)00884838061613(21)B1ML0V, (01)00884838061613(21)B1MNCG, (01)0088483806161
989605412042, 989605438541, 989605388071, 989605365003, 989605365001, 989605366331, 989605387852, 989605365004, 989605492481, 989605431531, 989605412072, 989606702251, 989605391092, 989605353303, 989605418552, 989605455171, 989605412041, 00884838061491, 00884838061507, 00884838061613
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.