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. 989605466201, 989606717071, 989605492481, 989605456291; UDI: (01)00884838088573(21)B3FMNT, (01)00884838102606(21)B3FLM3, (01)00884838102606(21)B411GD, (01)00884838102606(21)F053BY, (01)00884838102606(21)F0HT0R, 010088483810260621B3Y0MP, (01)00884838102606(21)F0KG9X, (01)00884838088573(21)B3FLWW, (01)00884838102606(21)F0HT11, (01)00884838102606(21)F04XCK, 010088483810260621F0FQZG, 010088483810260621F0FVH7, (01)00884838102606(21)F06PQM, (01)00884838102606(21)F06TGM, (01)00884838088573(21)B32TQN, (01)00884838102606(21)F0HJWD, (01)00884838102606(21)F0986F, (01)00884838102606(21)F07D1M, (01)00884838088573(21)B32TQZ, (01)00884838088573(21)B32TWD, (01)00884838088573(21)B32V4Y, (01)00884838102606(21)F09LH5, (01)00884838102606(21)F0JZJM, (01)00884838102606(21)F0576P, (01)00884838102606(21)F0CN2B, (01)00884838102606(21)F0F02Q, (01)00884838102606(21)F0JL42, (01)00884838088573(21)B3FLCN, (01)00884838088573(21)B3FMXB, (01)00884838088573(21)B2PYFR, (01)00884838088573(21)B2ZR1X, (01)00884838088573(21)B32V5Y, (01)00884838088573(21)B3FMPD, (01)00884838088573(21)B3FMPR, (01)00884838088573(21)B3FMPV, (01)00884838088573(21)B3FMQ5, (01)00884838088573(21)B3FMR6, (01)00884838102606(21)F0BHVR, (01)00884838102606(21)F0JWZG, (01)00884838102606(21)F0HJWH, (01)00884838088573(21)B3FMQ0, (01)00884838102606(21)F04XD2, (01)00884838102606(21)B3XYZG, (01)00884838102606(21)F0CHGT, (01)00884838088573(21)B32TWR, (01)00884838088573(21)B32V6B, (01)00884838102606(21)F073H5, (01)00884838088573(21)B3FMFT, (
989605466201, 989606717071, 989605492481, 989605456291, 00884838088573, 00884838102606, 00884838090804
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.