--- title: "S8-3 Transducer Probe — FDA record Z-2397-2025 | Is It on Recall" description: "To provide clarification and labelling to define the useful life of ultrasound transducers in the field." url: https://isitonrecall.com/recall/fda-device-z-2397-2025-s8-3-transducer-probe/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # S8-3 Transducer Probe — FDA record Z-2397-2025 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Jul 3, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: S8-3 Transducer Probe - **Reason**: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. - **Classification**: Class III - **Recalling firm**: Philips Ultrasound, Inc - **Quantity**: 171,322 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-2397-2025 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2397-2025%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | Model No. 989605361882, 989605440752, 989605361963, 989605438401, 989605387401, 989605387421, 989605400802, 989605361961, 989605361881, 989605362004, 989605362002, 21750A, 989605362003, 989605440682; UDI: (01)00884838067806(21)B2D78M, (01)00884838067806(21)B2PXNB, (01)00884838067806(21)B2TFQK, (01)00884838067806(21)B2TFQL, (01)00884838067806(21)B2TGWJ, (01)00884838067806(21)B2TGWP, (01)00884838067806(21)B3FQQB, (01)00884838067806(21)B3LC7N, (01)00884838067622(21)B3KM0K, (01)00884838067929(21)B20KQ4, (01)00884838067806(21)B2PXHR, (01)00884838067806(21)B20GMQ, (01)00884838067806(21)B2H3T2, (01)00884838067806(21)B20H2W, (01)00884838067806(21)F09M9D, (01)00884838067806(21)B3LGXW, (01)00884838067806(21)B2DF83, (01)00884838067806(21)B2PXW5, (01)00884838067806(21)F070MP, (01)00884838067806(21)F0J1R9, (01)00884838067806(21)B1MWN1, (01)00884838067806(21)B1MWQ5, (01)00884838067806(21)B27J9L, 010088483806780621F0FGBV, N/A, (01)00884838067806(21)B2D8JJ, (01)00884838067929(21)B24R5L, (01)00884838067806(21)B27PJL, (01)00884838067806(21)B1MWN0, (01)00884838067806(21)F0J9KW, (01)00884838067806(21)B2H4DL, (01)00884838067806(21)F0595D, (01)00884838067806(21)B40R7D, N/A, (01)00884838067806(21)F0L03V, (01)00884838067806(21)F0BPZP, (01)00884838067806(21)B24JJM, (01)00884838067806(21)B27R2N, (01)00884838067806(21)B2D78D, (01)00884838067806(21)B2D7RV, (01)00884838067806(21)B2D7V5, N/A, (01)00884838067806(21)B2H6RB, (01)00884838067806(21)B1RJTM, (01)00884838067806(21)F0HL8B, (01)00884838067806(21)F0HTF1, (01)00884838067806(21)B1N43T, N/A, (01)00884838067806(21)B2H4M3, (01)00884838067806(21)B1MW3P, (01)00884838067806(21)F08XR7, (01)00884838067806(21)F0HYKV, 010088483806780621F0G0FG, (01)00884838067806(21)B1MV6Z, (01)00884838067806(21)B1MV82, (01)00884838067806(21)B1MV8C, (01)00884838067622(21)B287Q3, (01)00884838067806(21)B2PTM2, (01)00884838067806(21)B1JWL7, N/A, (01)00884838067806(21)B1WVWQ, (01)00884838067806(21)B1WWJ4, (01)00884838067806(21)B1WX52, (01)00884838067806(21)B1WX5K, (01)00884838067806(21)B2DC9C, (01)00884838067806(21)B2PN7J, (01)00884838067806(21)F0JG6G, (01)00884838067806(21)F0DZWB, (01)00884838067806(21)F0F6M5, (01)00884838067806(21)F0H47P, (01)00884838067929(21)B2GZL2, N/A, (01)00884838067806(21)F08M68, (01)00884838067806(21)B2DCK5, (01)00884838067929(21)B20F7R, N/A, (01)00884838067806(21)B1WXH6, (01)00884838067806(21)B20F4C, (01)00884838067806(21)B20F76, N/A, N/A, (01)00884838067929(21)B20H54, N/A, (01)00884838067806(21)B1WWFV, N/A, N/A, N/A, (01)00884838067806(21)B2H7KN, (01)00884838067806(21)F0B5P3, N/A, (01)00884838067806(21)B24G9W, (01)00884838067806(21)B27PN0, N/A, (01)00884838067929(21)B2PTK7, (01)00884838067806(21)F0FM7R, (01)00884838067806(21)F09JR8, N/A, (01)00884838067806(21)B27HHK, (01)00884838067806(21)B27J8Y, (01)00884838067806(21)B27JWR, (01)00884838067806(21)B27QKH, N/A, (01)00884838067806(21)B3XC3V, (01)00884838067806(21)F0BWB5, (01)00884838067929(21)B24G4Q, (01)00884838067929(21)B1MWCC, (01)00884838067806(21)B20L19, (01)00884838067806(21)B1WWBY, (01)00884838067806(21)F0FHYX, (01)00884838067929(21)B3X88P, N/A, (01)00884838067806(21)B1RMK0, (01)00884838067929(21)B2PQ7N, N/A, (01)00884838067806(21)B2DBZ2, (01)00884838067806(21)B2DCHQ, (01)00884838067806(21)B2DCQ4, (01)00884838067806(21)B24RRM, (01)00884838067806(21)B1MVR9, (01)00884838067806(21)B20GHF, N/A, (01)00884838067806(21)B1JWQ3, (01)00884838067806(21)B2DFFR, (01)00884838067929(21)B20F5B, N/A, N/A, N/A, (01)00884838067806(21)B2DF24, (01)00884838067806(21)B24GJB, (01)00884838067806(21)B24GLW, (01)00884838067806(21)B24GN8, (01)00884838067806(21)B2D86B, (01)00884838067622(21)B2C47P, (01)00884838067806(21)B27PTR, (01)00884838067806(21)B3ZNV1, (01)00884838067806(21)B40QJN, (01)00884838067806(21)B40QW0, (01)00884838067806(21)B40QWB, (01)00884838067806(21)B40R21, (01)00884838067806(21)B40RCY, (01)00884838067806(21)B40XVM, (01)00884838067806(21)B40XVR, N/A, N/A, N/A, N/A, N/A, (01)00884838067806(21)B2DCFL, (01)00884838067622(21)B1F3GL, (01)00884838067806(21)B1MV62, (01)00884838067806(21)B40QND, (01)00884838067806(21)F07DVQ, (01)00884838067806(21)F07K6T, (01)00884838067806(21)B2PYCJ, (01)00884838067806(21)B2TRZZ, (01)00884838067806(21)B2DF22, (01)00884838067806(21)B2DFQH, (01)00884838067806(21)B2GZMH, N/A, (01)00884838067806(21)B2PV71, (01)00884838067806(21)B27JCG, (01)00884838067806(21)B3FR5H, (01)00884838067806(21)B1N0F1, (01)00884838067806(21)B2PNBM, N/A, (01)00884838067806(21)B32RK6, (01)00884838067806(21)B1WWG3, (01)00884838067806(21)B24JL6, (01)00884838067806(21)B1RF80, (01)00884838067929(21)B1RMXV, (01)00884838067929(21)B2ZLFJ, N/A, N/A, (01)00884838067806(21)B24JQ0, (01)00884838067806(21)B2H3XG, (01)00884838067806(21)B2H429, (01)00884838067806(21)B2H441, (01)00884838067806(21)B2H7B2, (01)00884838067806(21)B3X7R4, (01)00884838067806(21)B3XBM0, (01)00884838067806(21)B1X21Z, (01)00884838067806(21)B1X2FC, (01)00884838067806(21)B20DR6, N/A, (01)00884838067806(21)B20KHW, (01)00884838067806(21)B1MWG8, (01)00884838067806(21)B27R0J, (01)00884838067806(21)B1RRB8, (01)00884838067806(21)B2PTFV, (01)00884838067806(21)B39R49, (01)00884838067806(21)B27R01, (01)00884838067806(21)B20L32, N/A, N/A, N/A, (01)00884838067806(21)B1RMZG, (01)00884838067806(21)B1WTT3, (01)00884838067806(21)B1WXHK, (01)00884838067806(21)B1X1ZC, (01)00884838067806(21)B27T1L, (01)00884838067806(21)B1X2B8, N/A, (01)00884838067806(21)B20L1D, N/A, (01)00884838067806(21)B24GV4, N/A, (01)00884838067806(21)B1RJMB, (01)00884838067806(21)B2ZRQX, (01)00884838067806(21)B24GDR, (01)00884838067806(21)B1MV69, N/A, (01)00884838067806(21)B1JWHM, (01)00884838067806(21)B27JWP, (01)00884838067806(21)F09G0Z, (01)00884838067806(21)B2DF80, (01)00884838067806(21)B1JWX7, (01)00884838067806(21)B1RR7F, (01)00884838067806(21)B2ZR64, (01)00884838067806(21)B27K0P, (01)00884838067806(21)B27JLF, (01)00884838067806(21)B27JRB, (01)00884838067806(21)B2H8TQ, (01)00884838067806(21)B2PN4K, (01)00884838067806(21)B2PN79, (01)00884838067806(21)B1X2NP, (01)00884838067806(21)B2D82G, (01)00884838067806(21)B2DBYQ, (01)00884838067806(21)F07YKD, (01)00884838067806(21)B32RWG, (01)00884838067806(21)B40M4Z, (01)00884838067806(21)B1MWQ7, (01)00884838067806(21)B20DRN, (01)00884838067929(21)B20H5Y, (01)00884838067806(21)B1MV2Z, (01)00884838067806(21)B2H423, (01)00884838067806(21)B1WV3Q, (01)00884838067806(21)B1WV9X, (01)00884838067806(21)B1WVC0, N/A, (01)00884838067806(21)B1X2N6, (01)00884838067929(21)B1N083, N/A, (01)00884838067806(21)B24GN3, (01)00884838067806(21)B27HCW, (01)00884838067806(21)B20DZX, (01)00884838067806(21)B2PY1R, N/A, (01)00884838067806(21)B1RKCT, (01)00884838067806(21)B1JW6B, (01)00884838067806(21)B2H4DD, (01)00884838067806(21)B3W2P3, (01)00884838067806(21)F08W5X, (01)00884838067929(21)B1MVB1, (01)00884838067806(21)B20KPF, (01)00884838067806(21)B2DDY3, (01)00884838067806(21)B3FQXX, N/A, (01)00884838067806(21)B3FTL8, (01)00884838067806(21)F0BCX2, (01)00884838067929(21)B24RWC, (01)00884838067806(21)B1X2JF, N/A, N/A, (01)00884838067806(21)B1RMKV, (01)00884838067806(21)B3HW54, (01)00884838067806(21)B1RMQJ, (01)00884838067929(21)B2DFPX, (01)00884838067806(21)B2D7RQ, (01)00884838067806(21)B35F58, N/A, N/A, N/A, (01)00884838067929(21)B2TFY0, (01)00884838067806(21)B3YWTX, (01)00884838067806(21)B2H7LN, (01)00884838067806(21)B2PN7L, (01)00884838067806(21)B2DCFT, (01)00884838067806(21)B3Q4B8, (01)00884838067622(21)B1NMNB, (01)00884838067806(21)B24GZL, (01)00884838067806(21)B3Y23K, (01)00884838067806(21)B27J1K, (01)00884838067806(21)B27J67, (01)00884838067806(21)B27J6G, (01)00884838067806(21)B1N0QC, (01)00884838067806(21)B27JBH, (01)00884838067806(21)F08XQB, (01)00884838067929(21)B2TRNC, N/A, (01)00884838067929(21)B1WWLG, (01)00884838067929(21)B24RNX, (01)00884838067929(21)B2GZL3, (01)00884838067929(21)B2TFY3, (01)00884838067806(21)B40NBD, (01)00884838067806(21)B27QPY, (01)00884838067929(21)B24GC3, (01)00884838067806(21)B20KHV, (01)00884838067806(21)B2DCN6, (01)00884838067806(21)F0F1L2, N/A, N/A, (01)00884838067806(21)F0F8LP, (01)00884838067806(21)B20DPJ, N/A, (01)00884838061422(21)B2BP2T, N/A, (01)00884838067806(21)B1WV4R, (01)00884838067806(21)B3Y78Z, (01)00884838067806(21)B3YNLT, (01)00884838067806(21)F0H47B, (01)00884838067806(21)B3HRR6, (01)00884838067806(21)B1N0CW, (01)00884838067806(21)B1WWRH, (01)00884838067806(21)B32RML, (01)00884838067806(21)B32RMR, (01)00884838067806(21)F08PP1, (01)00884838067929(21)B1D9QN, (01)00884838067806(21)B1X2NY, (01)00884838067806(21)B27QJT, (01)00884838067806(21)B2ZKG9, N/A, (01)00884838067806(21)F0JDMF, (01)00884838067806(21)B1RQRP, (01)00884838067929(21)B2H8Z0, (01)00884838067929(21)B3HVHF, (01)00884838067929(21)B3YVHB, N/A, N/A, N/A, N/A, (01)00884838067806(21)B20KWR, (01)00884838067806(21)B20L8Y, N/A, (01)00884838067929(21)B1RJY0, (01)00884838067929(21)B35LHX, (01)00884838067929(21)B3HVHN, (01)00884838067622(21)B287RH, (01)00884838067806(21)B3ZN1J, (01)00884838067806(21)B2D7B9, (01)00884838067929(21)B1WWLL, N/A, (01)00884838067806(21)B24GWK, (01)00884838067806(21)B27QMC, N/A, N/A, (01)00884838067806(21)B1RDLX, (01)00884838067806(21)B35FKX, (01)00884838067806(21)B1RJMP, (01)00884838067806(21)B20KVC, (01)00884838067806(21)B27JL9, (01)00884838067806(21)B27JLB, (01)00884838067806(21)B3XVDB, (01)00884838067806(21)B3Z5PL, (01)00884838067806(21)B40LKX, (01)00884838067806(21)B1DG0V, (01)00884838067806(21)B24J2B, N/A, (01)00884838067806(21)B1MV0P, (01)00884838067806(21)B2ZKC2, (01)00884838067806(21)B2ZRQR, (01)00884838067806(21)B2D749, (01)00884838067806(21)B2D75L, (01)00884838067806(21)B24QJF, (01)00884838067806(21)B40Z9Y, N/A, (01)00884838067806(21)B2H4FF, (01)00884838067806(21)B2PTNR, (01)00884838067806(21)B2ZLD6, N/A, N/A, (01)00884838067806(21)B24QD3, (01)00884838067806(21)B1JWDT, (01)00884838067806(21)B27HCX, (01)00884838067806(21)B1MV5K, (01)00884838067806(21)B27QHQ, N/A, N/A, (01)00884838067806(21)B3HRQB, (01)00884838067806(21)B3W21R, (01)00884838067622(21)B288HD, (01)00884838067929(21)B2GZHV, N/A, (01)00884838067806(21)B20DPM, N/A, (01)00884838067806(21)F0B14N, (01)00884838067806(21)B20DYV, (01)00884838067806(21)B3LC5V, (01)00884838067929(21)B3HQBK, (01)00884838067806(21)B1MV2V, (01)00884838067806(21)B2D86H, (01)00884838067806(21)B2PXN7, (01)00884838067806(21)B2D7YX, (01)00884838067806(21)B35LB5, (01)00884838067806(21)B3X6JT, (01)00884838067806(21)B3YMDH, (01)00884838067806(21)F09M8Y, (01)00884838067806(21)B2DCFG, N/A, (01)00884838067806(21)B20F48, (01)00884838067806(21)B20GGY, (01)00884838067806(21)B20GTB, N/A, (01)00884838067806(21)B2D7VB, (01)00884838067806(21)B1MVDJ, (01)00884838067929(21)B24J6B, (01)00884838067806(21)B1N07Y, (01)00884838067806(21)B3Y1DC, (01)00884838067806(21)B1RJKN, (01)00884838067806(21)B1MWKQ, (01)00884838067806(21)B1MWN2, (01)00884838067806(21)B20L14, N/A, (01)00884838067806(21)B2PMP6, (01)00884838067806(21)F0H47H, (01)00884838067806(21)B20DGF, (01)00884838067806(21)B27J9K, (01)00884838067806(21)B20H38, N/A, (01)00884838067806(21)B1RDLR, (01)00884838067806(21)B2DF86, (01)00884838067806(21)B3XVJ3, N/A, (01)00884838067806(21)B32QYM, (01)00884838067806(21)F0F1KK, (01)00884838067806(21)B1WWH4, (01)00884838067806(21)B20Q3N, N/A, (01)00884838067806(21)B1RJHB, N/A, (01)00884838067806(21)B2H0WP, (01)00884838067806(21)B3PXL2, (01)00884838067806(21)B27TDF, (01)00884838067806(21)B40QPQ, (01)00884838067806(21)B40QPT, (01)00884838067806(21)B40R20, (01)00884838067806(21)B40T3P, (01)00884838067806(21)F07GJ7, N/A, N/A, (01)00884838067806(21)B24G86, (01)00884838067806(21)B1WWRQ, (01)00884838067806(21)B1WWWH, (01)00884838067806(21)B40QWC, (01)00884838067806(21)B1MWM9, (01)00884838067806(21)B1MV0W, (01)00884838067806(21)B27PH9, (01)00884838067806(21)B27QHT, (01)00884838067806(21)B27QHV, (01)00884838067806(21)B2PY26, (01)00884838067806(21)B40QNP, (01)00884838067806(21)B40R27, (01)00884838067806(21)B2DCGH, (01)00884838067806(21)B2DCK2, (01)00884838067806(21)B3HV1J, (01)00884838067806(21)B3HY69, (01)00884838067806(21)B2H1D8, (01)00884838067806(21)B20KWW, (01)00884838067806(21)B1JWC0, (01)00884838067806(21)B1JWHL, (01)00884838067806(21)B1JWPY, ... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2397-2025%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution US Nationwide distribution. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Sep 3, 2025 - **Recall initiation date**: Jul 3, 2025 - **Center classification date**: Aug 22, 2025 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2397-2025%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Philips Ultrasound, Inc. records](https://isitonrecall.com/brand/philips-ultrasound-inc/)