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. 989605359593, 989605387371, 989605359594, 989605359591; UDI: (01)00884838067950(21)B20N4N, (01)00884838067950(21)B1WR9H, (01)00884838067950(21)B1RGN0, (01)00884838067950(21)B1MTT4, (01)00884838067950(21)B1N3C4, (01)00884838087170(21)B27LPZ, (01)00884838087170(21)B3W5CM, (01)00884838067950(21)B24KL3, (01)00884838067950(21)B1MTT5, (01)00884838087170(21)B27LQ2; Serial No. B20N4N, B1WR9H, B1RGN0, B1MTT4, B16QBM, B1N3C4, B27LPZ, 03DG3C, B3W5CM, B2ZN6B, B19M3K, B2TJFT, B35M7F, B24KL3, B1MTT5, B32P04, B35MC6, B27LQ2.
989605359593, 989605387371, 989605359594, 989605359591, 00884838067950, 00884838087170
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.