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. 989605361882, 989605440752, 989605361963, 989605438401, 989605387401, 989605387421, 989605400802, 989605361961, 989605361881, 989605362004, 989605362002, 21750A, 989605362003, 989605440682; UDI: (01)00884838067806(21)B2D78M, (01)00884838067806(21)B2PXNB, (01)00884838067806(21)B2TFQK, (01)00884838067806(21)B2TFQL, (01)00884838067806(21)B2TGWJ, (01)00884838067806(21)B2TGWP, (01)00884838067806(21)B3FQQB, (01)00884838067806(21)B3LC7N, (01)00884838067622(21)B3KM0K, (01)00884838067929(21)B20KQ4, (01)00884838067806(21)B2PXHR, (01)00884838067806(21)B20GMQ, (01)00884838067806(21)B2H3T2, (01)00884838067806(21)B20H2W, (01)00884838067806(21)F09M9D, (01)00884838067806(21)B3LGXW, (01)00884838067806(21)B2DF83, (01)00884838067806(21)B2PXW5, (01)00884838067806(21)F070MP, (01)00884838067806(21)F0J1R9, (01)00884838067806(21)B1MWN1, (01)00884838067806(21)B1MWQ5, (01)00884838067806(21)B27J9L, 010088483806780621F0FGBV, N/A, (01)00884838067806(21)B2D8JJ, (01)00884838067929(21)B24R5L, (01)00884838067806(21)B27PJL, (01)00884838067806(21)B1MWN0, (01)00884838067806(21)F0J9KW, (01)00884838067806(21)B2H4DL, (01)00884838067806(21)F0595D, (01)00884838067806(21)B40R7D, N/A, (01)00884838067806(21)F0L03V, (01)00884838067806(21)F0BPZP, (01)00884838067806(21)B24JJM, (01)00884838067806(21)B27R2N, (01)00884838067806(21)B2D78D, (01)00884838067806(21)B2D7RV, (01)00884838067806(21)B2D7V5, N/A, (01)00884838067806(21)B2H6RB, (01)00884838067806(21)B1RJTM, (01)00884838067806(21)F0HL8B, (01)00884838067806(21)F0
989605361882, 989605440752, 989605361963, 989605438401, 989605387401, 989605387421, 989605400802, 989605361961, 989605361881, 989605362004, 989605362002, 989605362003, 989605440682, 00884838067806, 00884838067622, 00884838067929, 00884838061422, 00884838068100
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.