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. 989803002685, 989605416131, 989605408153, 989605430232, 989605416141, 989605364943, 989605388111, 989605387261, 989605408151, 989605361973, 989605408141, 989605430242, 989605364941; UDI: (01)00884838067745(21)B1YRNV, (01)00884838067981(21)B35BZF, (01)00884838067981(21)B24PBY, (01)00884838067981(21)B27T4Z, (01)00884838067981(21)B35H6L, (01)00884838067981(21)B1RPRM, (01)00884838068032(21)B2DGF2, (01)00884838067981(21)B1MZ1D, (01)00884838067981(21)B1X19N, (01)00884838067981(21)B1MYCZ, (01)00884838067981(21)B1RKT8, (01)00884838067981(21)B3PYXD, (01)00884838067981(21)B2TL3C, (01)00884838067981(21)B20NKJ, (01)00884838068032(21)B1X2X3, (01)00884838068032(21)B2TN85, (01)00884838068032(21)B2TTB8, (01)00884838068032(21)B2ZHBM, (01)00884838068032(21)B2ZHDD, (01)00884838067981(21)B2TKV5, (01)00884838067981(21)B40GX1, (01)00884838068032(21)B1RRJL, (01)00884838067981(21)B3ZCR0, (01)00884838067981(21)F09JPD, (01)00884838067981(21)B20G80, (01)00884838067981(21)B2PKDF, (01)00884838067981(21)B2TL8Y, (01)00884838067981(21)B20NHL, (01)00884838064577(21)B1YRVW, (01)00884838067981(21)B1RQDW, (01)00884838067981(21)B24FWM, (01)00884838067981(21)B2PKT2, (01)00884838067981(21)B35P3D, (01)00884838067981(21)F08W6H, (01)00884838067981(21)B35C6P, (01)00884838067981(21)B1MXNG, (01)00884838067981(21)B20HV9, (01)00884838064577(21)B1F3XP, (01)00884838064577(21)B1F3RL, (01)00884838067981(21)B1MXCF, (01)00884838067981(21)B1RPML, (01)00884838067981(21)B39MMX, (01)00884838067981(21)B39RBC, (01)008848380
989803002685, 989605416131, 989605408153, 989605430232, 989605416141, 989605364943, 989605388111, 989605387261, 989605408151, 989605361973, 989605408141, 989605430242, 989605364941, 00884838067745, 00884838067981, 00884838068032, 00884838064577, 00884838067936, 00884838068018
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.