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. 989605413712, 989605438601, 989605391092; UDI: (01)00884838061507(21)B2KPHY, (01)00884838067837(21)B1JT51, (01)00884838067837(21)B1JTFN, (01)00884838067837(21)B1JTJY, (01)00884838067837(21)B1MT19, (01)00884838067837(21)B1MT9L, (01)00884838067837(21)B1MT9X, (01)00884838067837(21)B1MT9Y, (01)00884838067837(21)B1MTDR, (01)00884838067837(21)B1MTDX, (01)00884838067837(21)B1MTDZ, (01)00884838067837(21)B1MTY9, (01)00884838067837(21)B1N32V, (01)00884838067837(21)B1N33Y, (01)00884838067837(21)B1N340, (01)00884838067837(21)B1N34V, (01)00884838067837(21)B1N352, (01)00884838067837(21)B1N383, (01)00884838067837(21)B1N3CX, (01)00884838067837(21)B1N3FT, (01)00884838067837(21)B1N3MR, (01)00884838067837(21)B1N3MT, (01)00884838067837(21)B1N3V5, (01)00884838067837(21)B1RGK2, (01)00884838067837(21)B1RGL6, (01)00884838067837(21)B1RGL9, (01)00884838067837(21)B1RGR1, (01)00884838067837(21)B1RNJZ, (01)00884838067837(21)B1RNK5, (01)00884838067837(21)B1RNND, (01)00884838067837(21)B1RNQQ, (01)00884838067837(21)B1RNQR, (01)00884838067837(21)B1RP18, (01)00884838067837(21)B1RP19, (01)00884838067837(21)B1RP1C, (01)00884838067837(21)B1RP70, (01)00884838067837(21)B1WQZ1, (01)00884838067837(21)B1WRGN, (01)00884838067837(21)B1WRJC, (01)00884838067837(21)B1WYX1, (01)00884838067837(21)B1WYX3, (01)00884838067837(21)B1WYZ7, (01)00884838067837(21)B1WYZB, (01)00884838067837(21)B1WZ00, (01)00884838067837(21)B1WZ02, (01)00884838067837(21)B1WZ23, (01)00884838067837(21)B1WZ26, (01)00884838067837(21)B1WZ2G, (01
989605413712, 989605438601, 989605391092, 00884838061507, 00884838067837
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.