Recall archive / FDA device enforcement
L12-4 Lumify Transducer Probe — FDA record Z-2374-2025
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. Source coverage and dates.
What the record says
- Product
- L12-4 Lumify 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-2374-2025
What the recall classes mean. 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. 989605434813, 989605451171, 989605434812, 989605477121, 989605434811; UDI: (01)00884838085169(21)B3GM1J, (01)00884838072305(21)B21GN4, (01)00884838085169(21)F07MZ5, (01)00884838068759(21)B21Z05, (01)00884838085169(21)B35YH3, (01)00884838085169(21)F0FG0Y, (01)00884838086586(21)B2C7QM, (01)00884838085169(21)B25WBT, (01)00884838085169(21)F01RBW, (01)00884838085169(21)F0CJ0M, (01)00884838085169(21)F0KW5F, (01)00884838085169(21)F00CDB, (01)00884838085169(21)F0DC9D, (01)00884838085169(21)F0DCLR, (01)00884838085169(21)F0DDF7, (01)00884838085169(21)F0DF57, (01)00884838085169(21)F0DF5D, (01)00884838085169(21)F02WK6, (01)00884838085169(21)F08PRN, (01)00884838085169(21)B2J24P, (01)00884838086586(21)B2C7PX, 010088483808516921B27DHQ, 010088483808516921B2J2CN, (01)00884838085169(21)F0F0B8, (01)00884838085169(21)F0FCP7, (01)00884838085169(21)B27CFY, (01)00884838085169(21)B27F3B, (01)00884838085169(21)F066CP, (01)00884838085169(21)F00PYH, (01)00884838085169(21)F0KTDZ, (01)00884838085169(21)F0J2M9, (01)00884838085169(21)B1L75L, (01)00884838085169(21)F037QC, (01)00884838085169(21)F07R0D, (01)00884838085169(21)F03FL7, (01)00884838085169(21)F0BMD1, (01)00884838061835(21)B1NJMW, (01)00884838061835(21)B1NJP2, (01)00884838061835(21)B1NJQZ, (01)00884838061835(21)B1NJR9, (01)00884838068759(21)B1QGV5, (01)00884838068759(21)B1QH43, (01)00884838068759(21)B1QH4K, (01)00884838068759(21)B1QH4Y, (01)00884838068759(21)B1QH50, (01)00884838068759(21)B1QH61, (01)00884838068759(21)B1QH6F, (01)00884838068759(21)B1XDZZ, (01)00884838068759(21)B1XF08, (01)00884838068759(21)B1XF34, (01)00884838068759(21)B1XF98, (01)00884838068759(21)B1XFC0, (01)00884838068759(21)B1XFFL, (01)00884838068759(21)B21Z08, (01)00884838068759(21)B21Z59, (01)00884838068759(21)B21ZCX, (01)00884838068759(21)B23H28, (01)00884838068759(21)B23H3X, (01)00884838068759(21)B23HB3, (01)00884838085169(21)B1FMZ9, (01)00884838085169(21)B1JNQF, (01)00884838085169(21)B1KFG3, (01)00884838085169(21)B1KFHL, (01)00884838085169(21)B1KFJN, (01)00884838085169(21)B1KFJR, (01)00884838085169(21)B1KFL7, (01)00884838085169(21)B1L717, (01)00884838085169(21)B1L744, (01)00884838085169(21)B1L75N, (01)00884838085169(21)B1L762, (01)00884838085169(21)B1L7BD, (01)00884838085169(21)B1QGWV, (01)00884838085169(21)B1QGYV, (01)00884838085169(21)B1QH17, (01)00884838085169(21)B1QH5F, (01)00884838085169(21)B1XF1G, (01)00884838085169(21)B1XF5C, (01)00884838085169(21)B1XF93, (01)00884838085169(21)B1XFF2, (01)00884838085169(21)B21Z6Y, (01)00884838085169(21)B21Z70, (01)00884838085169(21)B21Z7H, (01)00884838085169(21)B21ZC6, (01)00884838085169(21)B21ZCJ, (01)00884838085169(21)B21ZCM, (01)00884838085169(21)B23GT4, (01)00884838085169(21)B23GZF, (01)00884838085169(21)B23GZM, (01)00884838085169(21)B23H53, (01)00884838085169(21)B25W1Z, (01)00884838085169(21)B25W57, (01)00884838085169(21)B25W6K, (01)00884838085169(21)B27CDV, (01)00884838085169(21)B27CQ4, (01)00884838085169(21)B27CRD, (01)00884838085169(21)B27CT9, (01)00884838085169(21)B27CWL, (01)00884838085169(21)B27CWT, (01)00884838085169(21)B27CYB, (01)00884838085169(21)B27CYD, (01)00884838085169(21)B27CZX, (01)00884838085169(21)B27D2V, (01)00884838085169(21)B27D39, (01)00884838085169(21)B27D4W, (01)00884838085169(21)B27D80, (01)00884838085169(21)B27DCP, (01)00884838085169(21)B27DF0, (01)00884838085169(21)B27DH1, (01)00884838085169(21)B27DJ1, (01)00884838085169(21)B27DQR, (01)00884838085169(21)B27DWZ, (01)00884838085169(21)B27DXR, (01)00884838085169(21)B2J24M, (01)00884838085169(21)B2J250, (01)00884838085169(21)B2J272, (01)00884838085169(21)B2J2BG, (01)00884838085169(21)B2J2BH, (01)00884838085169(21)B2J2D7, (01)00884838085169(21)B2J2DF, (01)00884838085169(21)B2J2G1, (01)00884838085169(21)B2J2G3, (01)00884838085169(21)B2J2QB, (01)00884838085169(21)B2J2WB, (01)00884838085169(21)B2J2WL, (01)00884838085169(21)B2VLB5, (01)00884838085169(21)B2VLBN, (01)00884838085169(21)B2W738, (01)00884838085169(21)B2W9GN, (01)00884838085169(21)B2W9TT, (01)00884838085169(21)B2X00C, (01)00884838085169(21)B2X00F, (01)00884838085169(21)B2YB75, (01)00884838085169(21)B2YBGY, (01)00884838085169(21)B2YZVQ, (01)00884838085169(21)B30TD4, (01)00884838085169(21)B30VFG, (01)00884838085169(21)B31QX5, (01)00884838085169(21)B32B78, (01)00884838085169(21)B32BF7, (01)00884838085169(21)B34JLM, (01)00884838085169(21)B34TBL, (01)00884838085169(21)B37799, (01)00884838085169(21)B3CLZB, (01)00884838085169(21)B3KT6B, (01)00884838085169(21)B3MP00, (01)00884838085169(21)B3QB64, (01)00884838085169(21)B3QQZ8, (01)00884838085169(21)B3TXT8, (01)00884838085169(21)B3V78X, (01)00884838085169(21)B3V889, (01)00884838085169(21)B3VGRZ, (01)00884838085169(21)B3VGT2, (01)00884838085169(21)B3VGT8, (01)00884838085169(21)B3VGW3, (01)00884838085169(21)B3VPTG, (01)00884838085169(21)F008CR, (01)00884838085169(21)F010CY, (01)00884838085169(21)F0166C, (01)00884838085169(21)F01GR7, (01)00884838085169(21)F01NR3, (01)00884838085169(21)F054N2, (01)00884838085169(21)F087DJ, (01)00884838085169(21)F087DK, (01)00884838085169(21)F08KQ7, (01)00884838085169(21)F08X75, (01)00884838085169(21)F0930J, (01)00884838085169(21)F09400, (01)00884838085169(21)F09402, (01)00884838085169(21)F097RK, (01)00884838085169(21)F098HH, (01)00884838085169(21)F098HM, (01)00884838085169(21)F098HN, (01)00884838085169(21)F098HR, (01)00884838085169(21)F0999F, (01)00884838085169(21)F099B0, (01)00884838085169(21)F099JL, (01)00884838085169(21)F099JR, (01)00884838085169(21)F09CDW, (01)00884838085169(21)F09J0R, (01)00884838085169(21)F09J0V, (01)00884838085169(21)F09MML, (01)00884838085169(21)F09MMQ, (01)00884838085169(21)F09MMR, (01)00884838085169(21)F0B978, (01)00884838085169(21)F0BBLM, (01)00884838085169(21)F0CFVQ, (01)00884838085169(21)F0CJ0G, (01)00884838085169(21)F0CKXG, (01)00884838085169(21)F0CKXV, (01)00884838085169(21)F0CNHY, (01)00884838085169(21)F0CNJP, (01)00884838085169(21)F0CNJV, (01)00884838085169(21)F0CNT3, (01)00884838085169(21)F0CNT6, (01)00884838085169(21)F0CNT7, (01)00884838085169(21)F0CNT8, (01)00884838085169(21)F0CP0G, (01)00884838085169(21)F0CP0J, (01)00884838085169(21)F0CP0M, (01)00884838085169(21)F0CP0N, (01)00884838085169(21)F0CP0T, (01)00884838085169(21)F0CP0X, (01)00884838085169(21)F0CQMX, (01)00884838085169(21)F0CQMZ, (01)00884838085169(21)F0CQN0, (01)00884838085169(21)F0CQZF, (01)00884838085169(21)F0CYVH, (01)00884838085169(21)F0DC98, (01)00884838085169(21)F0DC99, (01)00884838085169(21)F0DCLP, (01)00884838085169(21)F0DCLX, (01)00884838085169(21)F0DCM0, (01)00884838085169(21)F0DCM1, (01)00884838085169(21)F0DCM2, (01)00884838085169(21)F0DCM3, (01)00884838085169(21)F0DDML, (01)00884838085169(21)F0DDZW, (01)00884838085169(21)F0DDZX, (01)00884838085169(21)F0DF02, (01)00884838085169(21)F0DF03, (01)00884838085169(21)F0DF53, (01)00884838085169(21)F0DF58, (01)00884838085169(21)F0DG2G, (01)00884838085169(21)F0DG9M, (01)00884838085169(21)F0DGNY, (01)00884838085169(21)F0DH76, (01)00884838085169(21)F0DJ82, (01)00884838085169(21)F0DKCV, (01)00884838085169(21)F0DLXM, (01)00884838085169(21)F0DLXT, (01)00884838085169(21)F0DLYJ, (01)00884838085169(21)F0DLYX, (01)00884838085169(21)F0DLZ5, (01)00884838085169(21)F0DLZ6, (01)00884838085169(21)F0DLZ7, (01)00884838085169(21)F0DMRH, (01)00884838085169(21)F0DMT9, (01)00884838085169(21)F0DNQ4, (01)00884838085169(21)F0DNQ7, (01)00884838085169(21)F0DNQ8, (01)00884838085169(21)F0DNQC, (01)00884838085169(21)F0DNQG, (01)00884838085169(21)F0DNQH, (01)00884838085169(21)F0DPJR, (01)00884838085169(21)F0DPJT, (01)00884838085169(21)F0DPJV, (01)00884838085169(21)F0DPJX, (01)00884838085169(21)F0DPK3, (01)00884838085169(21)F0DPK4, (01)00884838085169(21)F0DPN3, (01)00884838085169(21)F0DPN9, (01)00884838085169(21)F0DPND, (01)00884838085169(21)F0DPNG, (01)00884838085169(21)F0DPNJ, (01)00884838085169(21)F0DPNK, (01)00884838085169(21)F0DPNM, (01)00884838085169(21)F0DQDG, (01)00884838085169(21)F0DQDH, (01)00884838085169(21)F0DQDJ, (01)00884838085169(21)F0DQDM, (01)00884838085169(21)F0DTQC, (01)00884838085169(21)F0DTQD, (01)00884838085169(21)F0DTQG, (01)00884838085169(21)F0DTQH, (01)00884838085169(21)F0DTQJ, (01)00884838085169(21)F0DTQK, (01)00884838085169(21)F0DTQQ, (01)00884838085169(21)F0DX4T, (01)00884838085169(21)F0DX50, (01)00884838085169(21)F0F09W, (01)00884838085169(21)F0F09Y, (01)00884838085169(21)F0F0B2, (01)00884838085169(21)F0F0BC, (01)00884838085169(21)F0F0C8, (01)00884838085169(21)F0F0GJ, (01)00884838085169(21)F0F0GK, (01)00884838085169(21)F0F0GL, (01)00884838085169(21)F0F0GM, (01)00884838085169(21)F0F0GP, (01)00884838085169(21)F0F0GR, (01)00884838085169(21)F0F2ZG, (01)00884838085169(21)F0F31P, (01)00884838085169(21)F0F31Q, (01)00884838085169(21)F0F588, (01)00884838085169(21)F0F5KZ, (01)00884838085169(21)F0F7B2, 010088483808516921B27CG7, 010088483808516921F028ZX, 010088483808516921F02BL4, 010088483808516921F0B979, 010088483808516921F0BC4Y, 010088483808516921F0BD9P, (01)00884838068759(21)B23GRK, (01)00884838085169(21)B1XFG1, (01)00884838085169(21)B27D9N, (01)00884838085169(21)B2J2W2, (01)00884838085169(21)F00TNL, (01)00884838085169(21)F0FR8P, (01)00884838085169(21)F0FT1H, (01)00884838085169(21)F0HTQ4, (01)00884838085169(21)F0HV7C, (01)00884838085169(21)F0KX0V, (01)00884838085169(21)F0KXT5, (01)00884838085169(21)F0L0TN, (01)00884838086586(21)B2C7NK, (01)00884838086586(21)B2C7Q7, (01)00884838086586(21)B3F4ZP, (01)00884838086586(21)B3F4ZX, (01)00884838086586(21)F003CG, (01)00884838086586(21)F003CN, (01)00884838086586(21)F003D1, (01)00884838086586(21)F0165Y, (01)00884838086586(21)F01C68, (01)00884838086586(21)F027PP, (01)00884838086586(21)F02PB4, (01)00884838085169(21)B2J22Z, (01)00884838085169(21)B2J2JQ, (01)00884838085169(21)B35YJ0, (01)00884838085169(21)F0J3FN, (01)00884838085169(21)B27DCL, (01)00884838085169(21)B3RJW8, (01)00884838085169(21)B3RK1V, (01)00884838085169(21)F00MMX, (01)00884838085169(21)F00MNG, (01)00884838085169(21)F02VNV, (01)00884838085169(21)F038NT, (01)00884838085169(21)F043GF, (01)00884838085169(21)F0HM8W, (01)00884838085169(21)F0HM91, (01)00884838085169(21)F0HMPP, (01)00884838085169(21)F0HMPX, (01)00884838085169(21)F0JJXH, (01)00884838085169(21)B2YBBK, (01)00884838085169(21)F04700, (01)00884838085169(21)B2W755, (01)00884838085169(21)F02R91, (01)00884838085169(21)F02XQK, (01)00884838085169(21)F02XQX, (01)00884838085169(21)F02XRG, (01)00884838085169(21)B25W59, (01)00884838085169(21)B25W5Q, (01)00884838068759(21)B1QGX0, (01)00884838068759(21)B1QGXN, (01)00884838068759(21)B1QH1B, (01)00884838085169(21)B3V79H, (01)00884838085169(21)F03ZTT, (01)00884838085169(21)F043LH, (01)00884838085169(21)F043NN, (01)00884838085169(21)F0587B, (01)00884838085169(21)F06916, (01)00884838085169(21)F06DVG, (01)00884838085169(21)F06FG6, (01)00884838085169(21)F06HMT, (01)00884838085169(21)F085ZZ, (01)00884838085169(21)F08BYK, (01)00884838085169(21)F08BYL, (01)00884838085169(21)B27CZK, (01)00884838085169(21)B27CZW, (01)00884838085169(21)F0F63G, (01)00884838085169(21)F0F63L, (01)00884838085169(21)F0JJ7D, (01)00884838085169(21)F00K4D, (01)00884838085169(21)F00LPZ, (01)00884838085169(21)F02ZLH, (01)00884838085169(21)F0GN4D, 010088483808516921F0GNLV, (01)00884838085169(21)B3VH2Q, (01)00884838068759(21)B1QH55, (01)00884838085169(21)B329YN, (01)00884838085169(21)B37D6V, (01)00884838085169(21)B25W0F, (01)00884838085169(21)B3G9NH, (01)00884838085169(21)B3G9NM, (01)00884838085169(21)F085ZP, (01)00884838085169(21)F05QY5, (01)00884838085169(21)F05ZW9, (01)00884838085169(21)F01B7K, (01)00884838085169(21)F067VN, (01)00884838085169(21)B39XDJ, (01)00884838085169(21)B3BYPC, (01)00884838086586(21)F01Y6X, (01)00884838086586(21)F0233C, (01)00884838068759(21)B1XF3N, (01)00884838068759(21)B1XF3T, (01)00884838068759(21)B1XFD8, (01)00884838085169(21)B27F1L, (01)00884838085169(21)F013L5, (01)00884838085169(21)F032GZ, (01)00884838085169(21)F038NM, (01)00884838085169(21)F038NQ, (01)00884838085169(21)F039J2, (01)00884838085169(21)B31QWF, (01)00884838085169(21)F00Y0D, (01)00884838085169(21)F05M4T, (01)00884838085169(21)F0H51T, (01)00884838085169(21)F0H536, (01)00884838085169(21)F00CD8, (01)00884838085169(21)F04BN0, (01)0088... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
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
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- 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.