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. 989605389252, 989605418972, 989605463411, 989605442141, 989605463411, 989605389251, 989605412042, 989605387091, 989605418971; UDI: (01)00884838061392(21)B1Q4CD, (01)00884838061392(21)B1YXKM, (01)00884838061392(21)B323T7, (01)00884838061392(21)F00QWD, (01)00884838061392(21)F029RH, (01)00884838067875(21)B1N3PG, (01)00884838067875(21)B1N3PZ, (01)00884838067875(21)B1N3TV, (01)00884838067875(21)B1N3W3, (01)00884838067875(21)B1N3ZJ, (01)00884838067875(21)B20M3Y, (01)00884838067875(21)B27LZD, (01)00884838067875(21)B27LZH, (01)00884838067875(21)B2TR7C, (01)00884838067875(21)B2ZMR5, (01)00884838067875(21)B32NH8, (01)00884838067875(21)B39VT0, (01)00884838067875(21)B410QW, (01)00884838067875(21)F05HKB, (01)00884838067875(21)F0JQQG, (01)04719873000050(21)B2PTCD, (01)04719873000050(21)B32PHY, 010088483806787521B3XMR5, N/A, N/A, N/A, N/A, N/A, N/A, N/A, (01)00884838067875(21)F0L3Z8, (01)00884838061392(21)B30WYR, (01)00884838067875(21)B3Z7ZM, (01)00884838061392(21)B232FN, (01)00884838061392(21)B25HKF, (01)00884838061392(21)B3LLMF, (01)00884838061392(21)B1WF1V, (01)00884838061392(21)B25JBQ, (01)00884838061392(21)B26BTD, (01)00884838061392(21)F07X9C, (01)00884838061392(21)F089ZV, (01)00884838067875(21)B1WZDW, (01)00884838067875(21)F08RGM, (01)00884838061392(21)B1ZV0G, (01)00884838061392(21)B1ZV0K, (01)00884838061392(21)B1ZV0M, (01)00884838061392(21)B1ZV2W, (01)00884838061392(21)B20233, (01)00884838061392(21)B2LTD7, (01)00884838061392(21)B2LTMJ, (01)00884838061392(21)B2LTP6, (01)0088
989605389252, 989605418972, 989605463411, 989605442141, 989605389251, 989605412042, 989605387091, 989605418971, 00884838061392, 00884838067875, 04719873000050, 00884838061613
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.