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. 989605406772, 989605439232, 21781A, 989606708921, 989605406771, 989605414122; UDI: (01)00884838061439(21)B21003, (01)00884838061439(21)B3DV68, (01)00884838061439(21)F09Q11, (01)00884838061439(21)B2HXGF, (01)00884838061439(21)F0FJZW, (01)00884838061439(21)F01L0D, (01)00884838061439(21)F02LYB, (01)00884838061439(21)B3JQNC, (01)00884838061439(21)B3JQND, (01)00884838067530(21)B1TDDC, (01)00884838067530(21)B1V2XQ, (01)00884838067530(21)B2HX6Y, N/A, (01)00884838061439(21)F0DZC5, (01)00884838061439(21)B2HXKB, (01)00884838061439(21)B2HXKJ, (01)00884838061439(21)B2HXL1, (01)00884838061439(21)B2HXL4, (01)00884838061439(21)B30FDR, (01)00884838061439(21)B30FDW, (01)00884838061439(21)B30FHX, (01)00884838061439(21)B3DV36, (01)00884838061439(21)F068H7, (01)00884838061439(21)B2HWXC, (01)00884838061439(21)B3JQNB, (01)00884838061439(21)F032XF, N/A, (01)00884838061439(21)B30FFN, (01)00884838061439(21)B3DVDD, 010088483806143921F0GH3M, (01)00884838061439(21)B1X57T, (01)00884838061439(21)B2HWZL, (01)00884838061439(21)B34TFG, (01)00884838061439(21)F080RW, (01)00884838067530(21)B2HX0Q, (01)00884838067530(21)B2HXGM, (01)00884838061439(21)B2HX0H, (01)00884838061439(21)B2HX69, (01)00884838061439(21)F080RX, (01)00884838061439(21)F0DXGZ, (01)00884838067530(21)B0H9H6, (01)00884838067530(21)B0KWX1, (01)00884838067530(21)B22FLD, (01)00884838067530(21)B2HX4M, N/A, N/A, N/A, N/A, (01)00884838061439(21)F0LPPF, (01)00884838061439(21)F0LPPG, (01)00884838061439(21)B1ZJ03, (01)00884838061439(21)B3JQQ5, (
989605406772, 989605439232, 989606708921, 989605406771, 989605414122, 00884838061439, 00884838067530, 00884838061668
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.