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. 989605438561, 989605412062; UDI: (01)00884838061354(21)B1XLGQ, (01)00884838061354(21)B2L6LQ, (01)00884838061354(21)B1YGH9, (01)00884838061354(21)F0F143, (01)00884838061354(21)B1YGN1, (01)00884838061354(21)B2Q6W8, (01)00884838061354(21)B2L6MM, (01)00884838061354(21)B2Q6PV, (01)00884838061354(21)B2Q6QF, (01)00884838061354(21)F0FYTZ, (01)00884838061354(21)F04N02, (01)00884838061354(21)B1YGJH, (01)00884838061354(21)B1YGJK, (01)00884838061354(21)B2L6LH, (01)00884838061354(21)B2L6LT, (01)00884838061354(21)F0D4X3, (01)00884838061354(21)B1N4NC, (01)00884838061354(21)B2Q6CZ, (01)00884838061354(21)B1YGHW, (01)00884838061354(21)B2Q6MJ, (01)00884838061354(21)B2Q6ML, (01)00884838061354(21)F0367V, (01)00884838061354(21)F0367Y, (01)00884838061354(21)B1XL7W, (01)00884838061354(21)B1XLF6, (01)00884838061354(21)B2L6LZ, (01)00884838061354(21)B2Q6JJ, (01)00884838061354(21)F07TXW, (01)00884838061354(21)F05L2W, (01)00884838061354(21)B1XLDJ, (01)00884838061354(21)F07XDK, (01)00884838061354(21)B1YGM2, (01)00884838061354(21)F08MVP, (01)00884838061354(21)F0F839, (01)00884838061354(21)F0F83D, (01)00884838061354(21)F0F8TP, (01)00884838061354(21)F02WL4, (01)00884838061354(21)B1XLH1, (01)00884838061354(21)B1YGMH, (01)00884838061354(21)B1YGMV, (01)00884838061354(21)B2Q6DF, (01)00884838061354(21)B1XLFC, (01)00884838061354(21)B1XLBL, (01)00884838061354(21)B1YGNB, (01)00884838061354(21)B2Q6HH, (01)00884838061354(21)B2Q6HK, (01)00884838061354(21)B2Q6HV, (01)00884838061354(21)F0F8TK, (01)0088483806135
989605438561, 989605412062, 00884838061354
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.