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. 989605495721; UDI: (01)00884838093935(21)F0FKJ7, 010088483809393521F0FRHZ, (01)00884838093935(21)B3XYRY, (01)00884838093935(21)B4161X, (01)00884838093935(21)F07K8J, (01)00884838093935(21)F0JTY0, (01)00884838093935(21)F04YTZ, (01)00884838093935(21)F0550K, (01)00884838093935(21)F094Y9, (01)00884838093935(21)F0GJC9, (01)00884838093935(21)B3XZRM, (01)00884838093935(21)F0KC6Y, (01)00884838093935(21)F0HP38, (01)00884838093935(21)F0F164, (01)00884838093935(21)F0KND1, (01)00884838093935(21)F04YV6, 010088483809393521B3Y0KC, (01)00884838093935(21)F0JZQ6, (01)00884838093935(21)F0JZQ7, (01)00884838093935(21)B3XZ5Q, (01)00884838093935(21)F07WW2, (01)00884838093935(21)F07WW9, (01)00884838093935(21)F07WWF, (01)00884838093935(21)F07WWJ, (01)00884838093935(21)F07WWL, (01)00884838093935(21)F07WWN, (01)00884838093935(21)F07WWP, (01)00884838093935(21)F07WWQ, (01)00884838093935(21)F07ZZ0, (01)00884838093935(21)F081V3, (01)00884838093935(21)F08H3V, (01)00884838093935(21)F05FK6, (01)00884838093935(21)F06GWZ, (01)00884838093935(21)F07D0C, (01)00884838093935(21)F0B94X, (01)00884838093935(21)F0GJCR, (01)00884838093935(21)B3FKZJ, (01)00884838093935(21)B3FKZN, (01)00884838093935(21)F0LC8N, (01)00884838093935(21)F04QBB, (01)00884838093935(21)F04V3M, (01)00884838093935(21)F04V3Q, (01)00884838093935(21)F04XDN, (01)00884838093935(21)F04XF1, (01)00884838093935(21)F04XF6, (01)00884838093935(21)F06XQF, (01)00884838093935(21)F0F4BF, (01)00884838093935(21)F0F4BN, (01)00884838093935(21)F0F7ZJ, (01)00884
989605495721, 00884838093935, 00884838093
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.