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. 989605439242, 21381A; UDI: (01)00884838067547(21)B0DTV4, (01)00884838067547(21)B01639, (01)00884838067547(21)B06NT3; Serial No. 0341YT, 0319CQ, 028NZW, B0RF1J, B0F31L, B0DTV4, B0C9XR, 02H0L8, B0KYGV, B01639, B06NT3, 03C68B, 03C8CW.
989605439242, 00884838067547
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.