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. 989605387361, 989605353303, 989605353301, 989605365003; UDI: (01)00884838061767(21)B3PV40, (01)00884838061767(21)B3JRCQ, (01)00884838061767(21)B1ZRXY, (01)00884838061767(21)B1ZRY3, (01)00884838061767(21)B2G5L6, (01)00884838061767(21)B2JFF8, (01)00884838061767(21)B2JZ26, (01)00884838061767(21)B2R3XW, (01)00884838061767(21)B2Y7FN, (01)00884838061767(21)B2YD2P, (01)00884838061767(21)B33XHX, (01)00884838061767(21)B37VC0, (01)00884838061767(21)B2RLWL, (01)00884838061767(21)B3NT2M, (01)00884838061767(21)B2KLVJ, (01)00884838061767(21)B2JF6F, (01)00884838061767(21)B2Y53M, (01)00884838061767(21)B2T51H, (01)00884838061767(21)B3JWZB, (01)00884838061767(21)B3RJ6B, (01)00884838061767(21)B3VBQP, (01)00884838061767(21)B2LL7Z, (01)00884838061767(21)B2Y7BL, (01)00884838061767(21)B22LK7, (01)00884838061767(21)B29JNQ, (01)00884838061767(21)B31CCC, (01)00884838061767(21)B3C6BP, (01)00884838061767(21)B3JRLK, (01)00884838061767(21)B2YNBX, (01)00884838061767(21)B1YQBZ, (01)00884838061767(21)B2ZBZC, (01)00884838061767(21)B1XP34, (01)00884838061767(21)B1Q45M, (01)00884838061767(21)B3J2LX, (01)00884838061767(21)B3RJFP, (01)00884838061767(21)B30GBZ, (01)00884838061767(21)B36PBF, (01)00884838061767(21)F022CP, (01)00884838061767(21)B1NXT9, (01)00884838061767(21)B1QBFT, (01)00884838061767(21)B1TV9K, (01)00884838061767(21)B26N6F, (01)00884838061767(21)B3J3HK, (01)00884838061767(21)F08TJC, (01)00884838061767(21)B251QV, (01)00884838061767(21)B2G38C, (01)00884838061767(21)B2MPDN, (01)00884838061767(
989605387361, 989605353303, 989605353301, 989605365003, 00884838061767
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.