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. 989605365021, 989605365023, 989605387291; UDI: (01)00884838064607(21)B1FZ1B, (01)00884838064607(21)B2KL13, (01)00884838064607(21)B30GDB, (01)00884838064607(21)B33HMW, (01)00884838064607(21)B3CL5L, (01)00884838064607(21)B1VKTB, (01)00884838064607(21)B2KL31, (01)00884838064607(21)B2JZ44, (01)00884838064607(21)B3GX1T, (01)00884838064607(21)B1XRF3, (01)00884838064607(21)B34QB8, (01)00884838064607(21)B1GFMQ, (01)00884838064607(21)B1RYG9, (01)00884838064607(21)B23TC6, (01)00884838064607(21)B1XRF1, (01)00884838064607(21)B1XN5J, (01)00884838064607(21)B1RYG6, (01)00884838064607(21)B2JTTX, (01)00884838064607(21)B3DLZ0, (01)00884838064607(21)B33XZB, (01)00884838064607(21)B1NPG7, (01)00884838064607(21)B1VJYF, (01)00884838064607(21)B3H0QV, (01)00884838064607(21)B3LNZH, (01)00884838064607(21)B31DH7, (01)00884838064607(21)B1RVCQ, (01)00884838064607(21)B34VJ7, (01)00884838064607(21)B3DC5D, (01)00884838064607(21)B1RYL2, (01)00884838064607(21)B1RVCR, (01)00884838064607(21)B1RYN1, (01)00884838064607(21)B1VJYH, (01)00884838064607(21)B31DH4, (01)00884838064607(21)B1MQJ5, (01)00884838064607(21)B23T6T, (01)00884838064607(21)B1RYJP, (01)00884838064607(21)B1ZRQM, (01)00884838064607(21)B1RYMZ, (01)00884838064607(21)B1QBG1, (01)00884838064607(21)B33XZD, (01)00884838064607(21)B3BWZ4, (01)00884838064607(21)B2KL87, (01)00884838064607(21)B3DLZ3, (01)00884838064607(21)B1RT45; Serial No. B1FZ1B, B2KL13, B30GDB, B33HMW, B3CL5L, B1VKTB, B2KL31, B2JZ44, B3GX1T, B1XRF3, B34QB8, B1GFMQ, B1F22H, B1RYG9,
989605365021, 989605365023, 989605387291, 00884838064607
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.