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: 40 units Lot/code info: Model No. 989605412401, 989605387311, 989605418552, 989605408173, 989605438481, 989605420231; UDI: (01)00884838067851(21)B27H7T, (01)00884838067974(21)B0B0B1, (01)00884838067851(21)B16RRG, (01)00884838067974(21)B0HWBM, (01)00884838067974(21)B0B39M, (01)00884838067851(21)B1N2FG, (01)00884838067851(21)B1DD6B, (01)00884838067851(21)B27GVB, (01)00884838067851(21)B27RQ7, (01)00884838067851(21)B1WT18, (01)00884838067851(21)B1N1JB; Serial No. B107H4, B106RJ, B02RKJ, B0PXC9, B03JZF, B107JF, B27H7T, B0B0B1, B106XL, B10CF6, B14HHX, B10BZF, B04PTM, B16RRG, 0392R5, B1JPC9, B1JQ8W, B0HWBM, B0B39M, B0XK56, B16L5T, B10BQ3, B0J9Q6, B106DF, B105C1, B1N2FG, B10CTM, B01QKF, B10C67, B0FD7B, B0M21H, B0P7ZP, B1DD6B, B0F6F2, B27GVB, B27RQ7, B14CBD, B14J0X, B1WT18, B1N1JB.
989605412401, 989605387311, 989605418552, 989605408173, 989605438481, 989605420231, 00884838067851, 00884838067974
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.