FDAFDA · Food and drugs·Recall number Z-2392-2025
S4-1 Lumify Transducer Probe
Published September 3, 2025 · Recall initiated: July 3, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Ultrasound, Inc
- Distributor
- US Nationwide distribution.
- Lot
- 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)00884838085183(21)F05XFX, (01)00884838074231(21)B1RCL1, (01)00884838074231(21)B1RCL5, (01)00884838074231(21)B1RCRY, (01)00884838074231(21)B21XQ9, (01)00884838074231(21)B21Y77, (01)00884838074231(21)B21YDT, (01)00884838085183(21)B1RCP6, (01)00884838085183(21)B1W8C1, (01)00884838085183(21)B1ZJWV, (01)00884838085183(21)B21XT8, (01)00884838085183(21)B21Y9W, (01)00884838085183(21)B21YD4, (01)00884838085183(21)B21YDP, (01)00884838085183(21)B25VMQ, (01)00884838085183(21)B278YF, (01)00884838085183(21)B27918, (01)00884838085183(21)B2794K, (01)00884838085183(21)B279CL, (01)00884838085183(21)B279FW, (01)00884838085183(21)B279HY, (01)00884838085183(21)B2D2BG, (01)00884838085183(21)B2D2C5, (01)00884838085183(21)B2D2M1, (01)00884838085183(21)B2D2N6, (01)00884838085183(21)B2D2Q7, (01)00884838085183(21)B2D2TQ, (01)00884838085183(21)B2D37Y, (01)00884838085183(21)B2D3C9, (01)00884838085183(21)B2D3CP, (01)00884838085183(21)B2Y9JW, (01)00884838085183(21)B31MC9, (01)00884838085183(21)B32B0F, (01)00884838085183(21)B39X7Y, (01)00884838085183(21)B3H94R, (01)00884838085183(21)F01788, (01)00884838085183(21)F03D7T, (01)00884838085183(21)F06V7F, (01)00884838085183(21)F07CBB, (01)00884838085183(21)F07CBC, (01)00884838085183(21)F07CBH, (01)00884838085183(21)F07CBJ, (01)00884838085183(21)F07CBM, (01)00884838085183(21)F07YQ8, (01)00884838085183(21)F07ZFN, (01)00884838085183(21)F07ZFV, (01)00884838085183(21)F080WT, (01)00884838085183(21)F0860H, (01)00884838085183(21)F087JV, (01)00884838085183(21)F087JW, (01)00884838085183(21)F087K6, (01)00884838085183(21)F087KF, (01)00884838085183(21)F087KG, (01)00884838085183(21)F08C95, (01)00884838085183(21)F08DNW, (01)00884838085183(21)F08DNY, (01)00884838085183(21)F08HYF, (01)00884838085183(21)F08VR6, (01)00884838085183(21)F08VR7, (01)00884838085183(21)F08Y5Q, (01)00884838085183(21)F08Y5T, (01)00884838085183(21)F08Y5V, (01)00884838085183(21)F08Y5X, (01)00884838085183(21)F08Y5Y, (01)00884838085183(21)F0910V, (01)00884838085183(21)F09116, (01)00884838085183(21)F09117, (01)00884838085183(21)F096ZT, (01)00884838085183(21)F097BN, (01)00884838085183(21)F097RY, (01)00884838085183(21)F09GV2, (01)00884838085183(21)F09K2W, (01)00884838085183(21)F09KB3, (01)00884838085183(21)F09KB9, (01)00884838085183(21)F09KBD, (01)00884838085183(21)F09KBG, (01)00884838085183(21)F09MNB, (01)00884838085183(21)F09PGF, (01)00884838085183(21)F09VY1, (01)00884838085183(21)F0BF63, (01)00884838085183(21)F0BMH2, (01)00884838085183(21)F0BMH5, (01)00884838085183(21)F0BMH8, (01)0088483808
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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