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. 989605455171, 989605400802, 989605409562, 989605414122; UDI: (01)00884838069718(21)B2DKRP, (01)00884838069718(21)B2XD88, (01)00884838069718(21)B3DRBX, (01)00884838069718(21)B3DRF0, (01)00884838069718(21)B3DRGX, (01)00884838069718(21)F0GWCW, (01)00884838069718(21)B277WX, (01)00884838069718(21)F04WX2, (01)00884838069718(21)F0B4PV, (01)00884838069718(21)B2VQJ5, (01)00884838069718(21)F010V3, (01)00884838069718(21)F042C2, (01)00884838069718(21)F06TQ3, (01)00884838069718(21)F086C1, (01)00884838069718(21)F086C2, (01)00884838069718(21)F08835, (01)00884838069718(21)F09BV3, (01)00884838069718(21)F0DK0W, (01)00884838069718(21)F0FDNF, (01)00884838069718(21)F0K1TQ, (01)00884838069718(21)F0K5JZ, (01)00884838069718(21)F0186H, (01)00884838069718(21)F03RVN, (01)00884838069718(21)F052P3, (01)00884838069718(21)F05445, (01)00884838069718(21)F0BRLQ, (01)00884838069718(21)F0D1XZ, (01)00884838069718(21)B2JHG3, (01)00884838069718(21)B39B92, (01)00884838069718(21)F0LW0Y, (01)00884838069718(21)F0LW10, (01)00884838069718(21)F02ZG0, (01)00884838069718(21)B3DRL7, (01)00884838069718(21)F016MN, (01)00884838069718(21)F02R78, (01)00884838069718(21)F04C9H, (01)00884838069718(21)F04ZB0, (01)00884838069718(21)F0640W, (01)00884838069718(21)F09JV7, (01)00884838069718(21)F0CPG5, (01)00884838069718(21)F0CY3N, (01)00884838069718(21)F0DT5W, (01)00884838069718(21)F0F1QM, (01)00884838069718(21)F0FLG7, (01)00884838069718(21)F0FRL7, (01)00884838069718(21)F0GMVF, (01)00884838069718(21)F0GR8T, (01)00884838069718(
989605455171, 989605400802, 989605409562, 989605414122, 00884838069718, 0100884838069
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.