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. 989605391092, 989605438431, 989605418552, 989605391091, 989605412042; UDI: (01)00884838061507(21)B3G8WQ, 010088483806150721F0G8PX, (01)00884838061507(21)B25KL1, (01)00884838061507(21)B2L2LB, 010088483806150721F0FWFW, 010088483806150721F0G0CF, (01)00884838061507(21)F02CP6, (01)00884838061507(21)B26BXV, (01)00884838061507(21)B28G5L, (01)00884838061507(21)B2FG9B, (01)00884838061507(21)B3G8M5, (01)00884838061507(21)F03V2C, (01)00884838061507(21)F040X0, (01)00884838061507(21)F0G485, (01)00884838061507(21)B3NLL9, (01)00884838061507(21)F03W2J, 010088483806150721F0G524, (01)00884838061507(21)B1ZXP6, (01)00884838061507(21)F03Y53, (01)00884838061507(21)F0860Z, (01)00884838061507(21)F0JPXD, (01)00884838061507(21)B331YR, (01)00884838061507(21)F05CDM, (01)00884838061507(21)F05DYV, (01)00884838061507(21)F05VLL, 010088483806150721F0G59Y, (01)00884838061507(21)B3RFXC, (01)00884838061507(21)F03TK9, (01)00884838061507(21)B22HP1, (01)00884838061507(21)B250V0, (01)00884838061507(21)B1PL8N, (01)00884838061507(21)B3MHJM, (01)00884838061507(21)B2FQDH, (01)00884838061507(21)F060VV, (01)00884838061507(21)F0H3CD, (01)00884838061507(21)B1Q584, (01)00884838061507(21)B1W051, 010088483806150721F0299F, (01)00884838061507(21)B1NW7V, (01)00884838061507(21)F0KL3Q, (01)00884838061507(21)B3JTJX, (01)00884838061507(21)F0LK5V, (01)00884838061507(21)F07XGB, (01)00884838061507(21)F080X4, (01)00884838061507(21)F0818R, (01)00884838061507(21)F09B0J, (01)00884838061507(21)B2FQPR, (01)00884838061507(21)B2KP1Y,
989605391092, 989605438431, 989605418552, 989605391091, 989605412042, 00884838061507, 00884838067851
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.