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. 989605438551, 989605412052, 989605400802; UDI: (01)00884838061347(21)B1XJV9, (01)00884838061347(21)B1XKWM, (01)00884838061347(21)B1YLM8, (01)00884838061347(21)B2RY5Q, (01)00884838061347(21)B33Z0G, (01)00884838061347(21)B33Z8X, (01)00884838061347(21)F07Y3Y, (01)00884838061347(21)F0DB0C, 010088483806134721F0GCXL, 010088483806134721F0G55C, N/A, (01)00884838061347(21)B1YLVZ, (01)00884838061347(21)B2YJM2, (01)00884838061347(21)F09VWC, N/A, (01)00884838061347(21)F052VD, (01)00884838061347(21)F087H0, (01)00884838061347(21)F08LH8, (01)00884838061347(21)F08WX7, (01)00884838061347(21)F0FBP8, N/A, (01)00884838061347(21)B1XKC3, (01)00884838061347(21)B1YKQL, (01)00884838061347(21)B1YLM2, (01)00884838061347(21)B1YLQJ, (01)00884838061347(21)B1YKJC, (01)00884838061347(21)B1XH5T, (01)00884838061347(21)B33YV3, (01)00884838061347(21)F031Z6, (01)00884838061347(21)F0D039, (01)00884838061347(21)B1XGDD, (01)00884838061347(21)B2YJ5F, (01)00884838061347(21)B2YJD7, (01)00884838061347(21)B33ZW9, (01)00884838061347(21)B33ZWX, (01)00884838061347(21)B33ZY3, (01)00884838061347(21)F02CMG, (01)00884838061347(21)F02JZ3, (01)00884838061347(21)F0F8T7, (01)00884838061347(21)F0FD89, N/A, N/A, (01)00884838061347(21)F042XV, (01)00884838061347(21)B2RXX3, 010088483806134721F01RMH, (01)00884838061347(21)F01Q38, (01)00884838061347(21)F0L5LJ, (01)00884838061347(21)F0L5LK, (01)00884838061347(21)F0LLW2, (01)00884838061347(21)B1YLZP, (01)00884838061347(21)F0CH17, (01)00884838061347(21)F0D7Q9, N/A, N/A, N/A, N/A,
989605438551, 989605412052, 989605400802, 00884838061347, 00884838061422
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.