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. 989606702251, 989605455171, 989605400802, 989605412042; UDI: (01)00884838093843(21)F0B2Q1, 010088483809384321F0GQ0H, (01)00884838093843(21)F0CD0N, (01)00884838093843(21)F0C1LB, (01)00884838093843(21)F03QX3, (01)00884838093843(21)F04HV1, (01)00884838093843(21)F0851Z, (01)00884838093843(21)F0BY6P, (01)00884838093843(21)F0FJPN, (01)00884838093843(21)F0GGZX, (01)00884838093843(21)F0JYX2, (01)00884838093843(21)F0J1ZT, (01)00884838093843(21)F0J3KH, (01)00884838093843(21)F0J3MD, (01)00884838093843(21)F0J52B, (01)00884838093843(21)F0J5TY, 010088483809384321F0GFC3, (01)00884838093843(21)F0LYRP, (01)00884838093843(21)F0LYRR, (01)00884838093843(21)F0DGGR, (01)00884838093843(21)F06Z9C, (01)00884838093843(21)F0C1NV, (01)00884838093843(21)F0GXM7, (01)00884838093843(21)F0JJPV, (01)00884838093843(21)F0L50Z, (01)00884838093843(21)F0L5CW, (01)00884838093843(21)F0LX6M, (01)00884838093843(21)F0M0H8, (01)00884838093843(21)F0CBZ7, (01)00884838093843(21)F0HXLR, (01)00884838093843(21)F0DC7Q, (01)00884838093843(21)F0DYVN, (01)00884838093843(21)F0G4FC, (01)00884838093843(21)F0JJP1, (01)00884838093843(21)F03FYP, (01)00884838093843(21)F06Y1P, (01)00884838093843(21)F06YJ9, (01)00884838093843(21)F06ZML, (01)00884838093843(21)F0C28J, (01)00884838093843(21)F0C290, (01)00884838093843(21)F0C9X0, (01)00884838093843(21)F0DWRB, (01)00884838093843(21)F0DYY6, (01)00884838093843(21)F0FJQ7, (01)00884838093843(21)F0FJRH, (01)00884838093843(21)F0GP64, (01)00884838093843(21)F0GRTX, (01)00884838093843(21)F0GTN
989606702251, 989605455171, 989605400802, 989605412042, 00884838093843, 008848380938
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.