Philips Ultrasound, Inc: S4-1 Lumify Transducer Probe

Hazard

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Details from the source

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.989605458222, 989605477101, 989605458221; UDI: (01)00884838085183(21)B3G9Q2, (01)00884838074231(21)B1RCZ0, (01)00884838074231(21)B1RD8W, (01)00884838074231(21)B1RDD9, (01)00884838074231(21)B1W89Q, (01)00884838074231(21)B1W8D2, (01)00884838085183(21)B2D2YM, (01)00884838074231(21)B21YB6, (01)00884838085183(21)B35Y6X, (01)00884838085183(21)B36B15, (01)00884838085183(21)B36B6J, (01)00884838086579(21)B2C7BV, (01)00884838085183(21)F0BH9V, (01)00884838085183(21)F0DDFJ, (01)00884838085183(21)F0DDFL, (01)00884838085183(21)F0DDZD, (01)00884838085183(21)F0DDZF, (01)00884838085183(21)F0DF0H, (01)00884838085183(21)F0FFWW, (01)00884838085183(21)F0FMM0, (01)00884838085183(21)F0FQ22, (01)00884838085183(21)F0FQ79, (01)00884838085183(21)F0FQ7B, (01)00884838085183(21)F089PW, (01)00884838085183(21)B3VTP6, (01)00884838085183(21)B21XV4, (01)00884838085183(21)B2795N, (01)00884838085183(21)B2795P, (01)00884838085183(21)B279F3, (01)00884838085183(21)F03BG3, (01)00884838085183(21)F043BH, (01)00884838085183(21)F0473N, (01)00884838085183(21)F04847, (01)00884838085183(21)F0FKM3, (01)00884838085183(21)F0FL0R, (01)00884838085183(21)F082PN, (01)00884838085183(21)F0KNL7, (01)00884838085183(21)F0KPPW, (01)00884838085183(21)F0KPQ0, (01)00884838085183(21)F051N0, (01)00884838085183(21)F051N3, (01)00884838085183(21)F051N5, (01)00884838085183(21)F056QT, (01)00884838085183(21)F058VC, (01)00884838085183(21)F058VG, (01)00884838085183(21)B1RCKP, (01)00884838085183(21)F03KHH, (01)00884838085183(21)B3D8DD, (01)

UPC codes

989605458222, 989605477101, 989605458221, 00884838085183, 00884838074231, 00884838086579

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.