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. 989605434813, 989605451171, 989605434812, 989605477121, 989605434811; UDI: (01)00884838085169(21)B3GM1J, (01)00884838072305(21)B21GN4, (01)00884838085169(21)F07MZ5, (01)00884838068759(21)B21Z05, (01)00884838085169(21)B35YH3, (01)00884838085169(21)F0FG0Y, (01)00884838086586(21)B2C7QM, (01)00884838085169(21)B25WBT, (01)00884838085169(21)F01RBW, (01)00884838085169(21)F0CJ0M, (01)00884838085169(21)F0KW5F, (01)00884838085169(21)F00CDB, (01)00884838085169(21)F0DC9D, (01)00884838085169(21)F0DCLR, (01)00884838085169(21)F0DDF7, (01)00884838085169(21)F0DF57, (01)00884838085169(21)F0DF5D, (01)00884838085169(21)F02WK6, (01)00884838085169(21)F08PRN, (01)00884838085169(21)B2J24P, (01)00884838086586(21)B2C7PX, 010088483808516921B27DHQ, 010088483808516921B2J2CN, (01)00884838085169(21)F0F0B8, (01)00884838085169(21)F0FCP7, (01)00884838085169(21)B27CFY, (01)00884838085169(21)B27F3B, (01)00884838085169(21)F066CP, (01)00884838085169(21)F00PYH, (01)00884838085169(21)F0KTDZ, (01)00884838085169(21)F0J2M9, (01)00884838085169(21)B1L75L, (01)00884838085169(21)F037QC, (01)00884838085169(21)F07R0D, (01)00884838085169(21)F03FL7, (01)00884838085169(21)F0BMD1, (01)00884838061835(21)B1NJMW, (01)00884838061835(21)B1NJP2, (01)00884838061835(21)B1NJQZ, (01)00884838061835(21)B1NJR9, (01)00884838068759(21)B1QGV5, (01)00884838068759(21)B1QH43, (01)00884838068759(21)B1QH4K, (01)00884838068759(21)B1QH4Y, (01)00884838068759(21)B1QH50, (01)00884838068759(21)B1QH61, (01)00884838068759(21)B1QH6F, (01)008848380
989605434813, 989605451171, 989605434812, 989605477121, 989605434811, 00884838085169, 00884838072305, 00884838068759, 00884838086586, 00884838061835
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.