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. 989605395642; UDI: (01)00884838061552(21)B29VPV, (01)00884838061552(21)B29VQ6, (01)00884838061552(21)B2CYJ4, (01)00884838061552(21)F06M63, (01)00884838061552(21)F06QYR, (01)00884838061552(21)B2CY7P, (01)00884838061552(21)F058R4, (01)00884838061552(21)B2CY8T, (01)00884838061552(21)F05YF6, (01)00884838061552(21)F0628C, (01)00884838061552(21)B29VPW, (01)00884838061552(21)F064N9, (01)00884838061552(21)F078HF, (01)00884838061552(21)F05Y6Y, (01)00884838061552(21)B2CYJJ, (01)00884838061552(21)B2CYD7; Serial No. B29VPV, B29VQ6, B2CYJ4, F06M63, F06QYR, B2CY7P, F058R4, B2CY8T, F05YF6, F0628C, B29VPW, F064N9, F078HF, F05Y6Y, B2CYJJ, B2CYD7.
989605395642, 00884838061552
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.