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. 989605418982, 989605418983, 989605463391, 989605463391, 989605442151, 989605387071, 989605418972; UDI: (01)00884838067868(21)B1N309, (01)00884838067868(21)B1N3GM, (01)00884838067868(21)B20LH9, (01)00884838087163(21)B27M92, (01)00884838087163(21)B2D4X5, (01)00884838087163(21)B2TQDL, (01)00884838087163(21)B2TQHL, (01)00884838087163(21)B2TR9L, (01)00884838087163(21)B2TR9R, (01)00884838087163(21)B32NLQ, (01)00884838087163(21)B32P57, (01)00884838087163(21)B3WW8C, (01)00884838087163(21)B40ZK4, (01)00884838087163(21)F05J29, (01)00884838087163(21)F0GGQZ, (01)04719873000036(21)B2TR3Y, (01)04719873000036(21)B3HZ2G, (01)04719873000036(21)F08334, (01)04719873000036(21)F0H6X0, 010088483808716321B3XNQK, 010471987300003621B2D52G, (01)00884838067868(21)B27KQ5, (01)00884838087163(21)F08BN7, (01)00884838067868(21)B1N327, (01)00884838067868(21)B1N35V, (01)00884838087163(21)B2THXY, (01)00884838087163(21)B2TJ1M, (01)00884838087163(21)B2ZMG6, (01)04719873000036(21)B3TKBZ, (01)04719873000036(21)B3W5VV, (01)04719873000036(21)F080L2, (01)00884838067868(21)B1WQXH, (01)00884838067868(21)B1WQZ5, (01)00884838067868(21)B1WR33, (01)00884838087163(21)B32Q2J, (01)00884838067868(21)B27KCV, (01)00884838067868(21)B27KNX, (01)00884838067868(21)B1N300, (01)00884838087163(21)F057NM, (01)00884838087163(21)F0HX1L, (01)00884838087163(21)B2PRZ1, (01)00884838067868(21)B24LLK, (01)00884838087163(21)B32NK1, (01)00884838067868(21)B20CNY, (01)00884838087163(21)B3W6RH, (01)00884838087163(21)F0552K, (01)00884838087
989605418982, 989605418983, 989605463391, 989605442151, 989605387071, 989605418972, 00884838067868, 00884838087163, 04719873000036
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.