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: Unique Device Identifier (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)0088483
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.