Recall archive / FDA device enforcement
C5-2 Lumify Transducer Probe — FDA record Z-2354-2025
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
- C5-2 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-2354-2025
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. 989605450353, 989605450352, 989605477131, 989605450351, 989605451181, 989605427371; UDI: 010088483808517621F0FYRG, (01)00884838085176(21)B3H57K, (01)00884838068766(21)B1W1CR, (01)00884838086555(21)B2C7Z5, (01)00884838085176(21)F07VCW, (01)00884838085176(21)F0J0P8, (01)00884838061828(21)B1MBZM, (01)00884838068766(21)B1W1NG, (01)00884838085176(21)B1MC3H, (01)00884838085176(21)B1QHPM, (01)00884838085176(21)B1W13D, (01)00884838085176(21)B1W153, (01)00884838085176(21)B27BC5, (01)00884838085176(21)B3PH0F, (01)00884838085176(21)B3R48C, (01)00884838085176(21)F02N98, (01)00884838085176(21)F07PWD, (01)00884838085176(21)F07TZ0, (01)00884838085176(21)F07Y64, (01)00884838085176(21)F081Y3, (01)00884838085176(21)F082NG, (01)00884838085176(21)F082NP, (01)00884838085176(21)F0855V, (01)00884838085176(21)F088RF, (01)00884838085176(21)F089MZ, (01)00884838085176(21)F089N6, (01)00884838085176(21)F08GBG, (01)00884838085176(21)F08GBX, (01)00884838085176(21)F08HWH, (01)00884838085176(21)F08KFK, (01)00884838085176(21)F08NKZ, (01)00884838085176(21)F08NL0, (01)00884838085176(21)F08NLH, (01)00884838085176(21)F08PR7, (01)00884838085176(21)F08PR8, (01)00884838085176(21)F08PR9, (01)00884838085176(21)F08PRB, (01)00884838085176(21)F08PRF, (01)00884838085176(21)F08WGJ, (01)00884838085176(21)F08ZVL, (01)00884838085176(21)F091X3, (01)00884838085176(21)F091X6, (01)00884838085176(21)F091X8, (01)00884838085176(21)F091X9, (01)00884838085176(21)F092MC, (01)00884838085176(21)F092MG, (01)00884838085176(21)F0B6FV, (01)00884838085176(21)B3QQNQ, (01)00884838085176(21)F0JXYX, (01)00884838085176(21)F0K0WB, (01)00884838085176(21)B25WHM, (01)00884838085176(21)B25WJ0, (01)00884838085176(21)F03X7G, (01)00884838085176(21)F03Y09, (01)00884838085176(21)F03ZNR, (01)00884838086555(21)B2C81X, (01)00884838085176(21)F09WM3, (01)00884838086555(21)B2C805, (01)00884838085176(21)F00JK2, (01)00884838068766(21)B1QHC0, (01)00884838085176(21)F019V5, (01)00884838085176(21)F0D7WH, (01)00884838068766(21)B1W1QT, (01)00884838085176(21)B30VF1, (01)00884838085176(21)F036T0, (01)00884838085176(21)F037Q6, (01)00884838085176(21)F037QB, (01)00884838085176(21)F09RBY, (01)00884838086555(21)F01L12, (01)00884838086555(21)F01VX1, (01)00884838085176(21)B279LY, (01)00884838085176(21)F0FXY3, (01)00884838085176(21)F0FZCD, (01)00884838085176(21)F05WH7, (01)00884838085176(21)F05RBG, (01)00884838072312(21)B25DXC, (01)00884838085176(21)B279KZ, (01)00884838085176(21)B279T4, (01)00884838085176(21)B27B0H, (01)00884838085176(21)B27B4Q, (01)00884838085176(21)B27BDC, (01)00884838085176(21)B27B1K, (01)00884838085176(21)B3H53P, (01)00884838085176(21)B3H555, (01)00884838085176(21)F02F5T, (01)00884838085176(21)B3C4KX, (01)00884838085176(21)B3G9RV, (01)00884838085176(21)B3J1W8, (01)00884838085176(21)B3J1WH, (01)00884838085176(21)B3J1Z1, (01)00884838086555(21)B2C814, (01)00884838085176(21)B3H58L, (01)00884838085176(21)B3H59N, (01)00884838085176(21)F0DLT8, (01)00884838072312(21)B3H970, (01)00884838085176(21)F03VJB, (01)00884838068766(21)B1QHDM, (01)00884838085176(21)B25WKM, (01)00884838085176(21)F0LHK5, (01)00884838072312(21)B25DY9, (01)00884838085176(21)B3LN01, (01)00884838085176(21)F0302B, 010088483808517621B279Z7, (01)00884838085176(21)B3JWM1, (01)00884838085176(21)F05T34, (01)00884838085176(21)F01W7N, (01)00884838085176(21)B30TJM, (01)00884838085176(21)F05J8N, (01)00884838072312(21)B1QJ53, (01)00884838072312(21)B3H91M, (01)00884838072312(21)B3H971, (01)00884838072312(21)B3H97Z, (01)00884838072312(21)F03JG6, (01)00884838072312(21)B38WQF, (01)00884838068766(21)B1W13F, (01)00884838085176(21)F03PRC, (01)00884838085176(21)F09Q46, (01)00884838085176(21)B27B83, (01)00884838085176(21)F07ZDW, (01)00884838085176(21)F0FCJJ, (01)00884838085176(21)F0KL1J, (01)00884838085176(21)B3D3ZM, (01)00884838085176(21)F0JC0F, (01)00884838085176(21)F0LPN8, (01)00884838085176(21)B27B72, (01)00884838085176(21)F0JR3R, (01)00884838085176(21)B3KZTH, (01)00884838072312(21)B23942, (01)00884838085176(21)B25WKG, (01)00884838085176(21)B3H9BF, (01)00884838085176(21)F0B6FT, (01)00884838085176(21)F0B904, (01)00884838085176(21)F0LHK2, (01)00884838085176(21)F0LGBK, (01)00884838085176(21)F00VT8, (01)00884838085176(21)F01W7M, (01)00884838085176(21)F0LDPH, (01)00884838085176(21)F0LQ48, (01)00884838085176(21)F0DLT9, (01)00884838085176(21)F0B8K3, (01)00884838085176(21)F00WJQ, (01)00884838085176(21)B2GB23, (01)00884838085176(21)B3V99J, (01)00884838085176(21)F03X72, (01)00884838085176(21)B3CLYQ, (01)00884838085176(21)F01N9V, (01)00884838085176(21)F01NM7, (01)00884838085176(21)F01NM9, (01)00884838085176(21)F0FW75, (01)00884838085176(21)F0FWF3, (01)00884838086555(21)B2C7X5, (01)00884838086555(21)B2C80J, (01)00884838086555(21)F01FKV, (01)00884838072312(21)B2394W, (01)00884838072312(21)B3H91W, (01)00884838085176(21)F0LPN9, (01)00884838085176(21)F02Y0G, (01)00884838085176(21)B3R40V, (01)00884838072312(21)B23959, (01)00884838085176(21)B279T6, (01)00884838072312(21)B3H52W, (01)00884838085176(21)B30TC1, (01)00884838085176(21)B3JRR6, (01)00884838085176(21)F08YQ4, (01)00884838085176(21)F0KN7X, (01)00884838085176(21)F03QJL, (01)00884838085176(21)F03RZ3, (01)00884838085176(21)F05WBH, (01)00884838085176(21)F05ZGB, (01)00884838085176(21)F0632Z, 010088483808517621F0G4ZP, (01)00884838085176(21)F00JJC, (01)00884838085176(21)F00RHN, (01)00884838085176(21)F00RTT, (01)00884838085176(21)F0KRLP, (01)00884838085176(21)B3G9T8, (01)00884838085176(21)B3J2QC, (01)00884838085176(21)B3KZLM, (01)00884838085176(21)B27BCY, (01)00884838085176(21)B30V22, (01)00884838085176(21)F0FV13, (01)00884838085176(21)F0FWF2, (01)00884838085176(21)F059CV, (01)00884838068766(21)B1W1TR, (01)00884838085176(21)B3CWH9, (01)00884838085176(21)B3CWHB, (01)00884838085176(21)B3D3ZK, (01)00884838085176(21)B27B06, (01)00884838085176(21)F043MM, (01)00884838085176(21)F02J7F, (01)00884838085176(21)B3DVVW, (01)00884838085176(21)B3F5BZ, (01)00884838085176(21)F00JJB, (01)00884838085176(21)B3H5B3, (01)00884838085176(21)B3C1VT, (01)00884838085176(21)F00XZP, (01)00884838085176(21)F0JK7F, (01)00884838085176(21)B3J1YZ, (01)00884838085176(21)F065F8, (01)00884838085176(21)F065FG, (01)00884838085176(21)F066C0, (01)00884838085176(21)F066C1, (01)00884838085176(21)F066C6, (01)00884838085176(21)F07NJ7, (01)00884838085176(21)F07NL5, (01)00884838085176(21)F07NL9, (01)00884838085176(21)F07P9T, (01)00884838085176(21)F07PV4, (01)00884838085176(21)F08QD4, (01)00884838085176(21)F0B23Q, (01)00884838085176(21)F0B30F, (01)00884838085176(21)F0B3MM, (01)00884838085176(21)F0CB8V, (01)00884838085176(21)F0CC2H, (01)00884838085176(21)F0D992, (01)00884838085176(21)F0D993, (01)00884838085176(21)F0DFBL, (01)00884838085176(21)B2VM05, (01)00884838085176(21)F05FTP, (01)00884838085176(21)B27B37, (01)00884838085176(21)B34JT6, (01)00884838085176(21)F094Z3, (01)00884838085176(21)F0BGB2, (01)00884838085176(21)B25WK9, (01)00884838085176(21)B25WKK, (01)00884838068766(21)B1QHNP, (01)00884838072312(21)B1XL2J, (01)00884838072312(21)B2393L, (01)00884838072312(21)B2393X, (01)00884838072312(21)B25F17, (01)00884838072312(21)B3H91Y, (01)00884838072312(21)B2393P, (01)00884838085176(21)B3V986, (01)00884838085176(21)B3V9JL, (01)00884838085176(21)B3VH33, (01)00884838085176(21)B3WDK5, (01)00884838085176(21)F037Q9, (01)00884838085176(21)F0CW49, (01)00884838085176(21)B3KHZP, (01)00884838085176(21)B3KHZR, (01)00884838085176(21)F000YF, (01)00884838068766(21)B1QHHY, (01)00884838068766(21)B1QHJ8, (01)00884838068766(21)B1QHQG, (01)00884838068766(21)B1W13B, (01)00884838068766(21)B1W17Z, (01)00884838068766(21)B1W1JR, (01)00884838068766(21)B1W1KX, (01)00884838068766(21)B1W1KZ, (01)00884838068766(21)B1W1L0, (01)00884838068766(21)B1W1M2, (01)00884838068766(21)B1W1M3, (01)00884838068766(21)B1W1M4, (01)00884838068766(21)B1W1M7, (01)00884838068766(21)B1W1MF, (01)00884838068766(21)B1W1N0, (01)00884838085176(21)B307R5, (01)00884838085176(21)B3RFMX, (01)00884838085176(21)F094J8, (01)00884838085176(21)B279WN, (01)00884838085176(21)F09K9F, (01)00884838085176(21)F09Q45, (01)00884838085176(21)B2G9TF, (01)00884838085176(21)B2G9X8, (01)00884838085176(21)F0CNPB, (01)00884838085176(21)F0D529, (01)00884838085176(21)F0D84V, (01)00884838085176(21)F0D8J3, (01)00884838085176(21)F0J2KH, (01)00884838085176(21)F0KL1N, (01)00884838086555(21)B2C810, (01)00884838085176(21)B27B32, (01)00884838085176(21)F048JY, (01)00884838086555(21)B2C81F, (01)00884838085176(21)B3KZNM, (01)00884838085176(21)B3KZNR, (01)00884838085176(21)B3LN0Q, (01)00884838085176(21)B3VH2N, (01)00884838085176(21)B3VH3V, (01)00884838085176(21)B3TXN8, (01)00884838085176(21)B3TXNC, (01)00884838085176(21)F08GBN, (01)00884838085176(21)F0467D, (01)00884838086555(21)F01L14, (01)00884838085176(21)F07PW5, 010088483808517621F028FW, (01)00884838085176(21)F01GBB, (01)00884838085176(21)B35Y6V, (01)00884838085176(21)B36B01, (01)00884838085176(21)B36B0G, (01)00884838085176(21)B36B0H, 010088483808517621F0GFVT, (01)00884838085176(21)B279VY, (01)00884838085176(21)B27B2K, (01)00884838085176(21)B27B2M, (01)00884838085176(21)B27B3W, (01)00884838085176(21)B27B8F, (01)00884838085176(21)B27BKQ, (01)00884838085176(21)B2G9VH, (01)00884838085176(21)B3H501, 010088483808517621F0G753, (01)00884838085176(21)F0LJFJ, (01)00884838085176(21)B3PH0G, (01)00884838085176(21)F0D34H, (01)00884838068766(21)B1W1KT, (01)00884838085176(21)B3VCFN, (01)00884838085176(21)B2G9X9, (01)00884838085176(21)B3PGVN, 010088483808517621F0G4ZM, 010088483808517621F0G66P, 010088483808517621F0G6Q1, (01)00884838086555(21)B2C7W9, (01)00884838086555(21)B2C7X4, (01)00884838086555(21)B2C7YP, (01)00884838086555(21)B2C81T, (01)00884838085176(21)F043HJ, (01)00884838085176(21)F0648H, (01)00884838085176(21)F06B4T, (01)00884838085176(21)F02ZBM, (01)00884838086555(21)B2C7WM, (01)00884838086555(21)B2C7ZW, (01)00884838085176(21)F094J6, (01)00884838085176(21)B27BDJ, (01)00884838085176(21)F03BHB, (01)00884838085176(21)F03BHD, (01)00884838085176(21)F03LVL, (01)00884838072312(21)B1XL4T, (01)00884838085176(21)F05T23, (01)00884838068766(21)B1QHD4, (01)00884838068766(21)B1QHKR, (01)00884838068766(21)B1QHLR, (01)00884838068766(21)B1QHN7, (01)00884838068766(21)B1QHQ1, (01)00884838068766(21)B1QHQP, (01)00884838085176(21)B25WJY, (01)00884838085176(21)B25WM9, (01)00884838085176(21)B279P8, (01)00884838085176(21)B279P9, (01)00884838085176(21)B279PM, (01)00884838085176(21)B279RC, (01)00884838085176(21)B27B49, (01)00884838085176(21)B27B4G, (01)00884838085176(21)B27B6B, (01)00884838085176(21)F0CNRQ, (01)00884838085176(21)F0BN56, (01)00884838085176(21)F0BP9N, (01)00884838068766(21)B1QHL0, (01)00884838068766(21)B1W1LG, (01)00884838085176(21)B3C1WD, (01)00884838085176(21)B3DVRJ, (01)00884838085176(21)B3DVV9, (01)00884838085176(21)B3DW1V, (01)00884838085176(21)B3GFPR, (01)00884838085176(21)F02F6H, (01)00884838085176(21)F0D4DH, (01)00884838085176(21)B3PKNJ, (01)00884838085176(21)B3R9NR, (01)00884838072312(21)B1XL4X, (01)00884838072312(21)B2394R, (01)00884838072312(21)B2395F, (01)00884838072312(21)B2396V, (01)00884838085176(21)B1MC3B, (01)00884838085176(21)F016W4, (01)00884838085176(21)F0177R, (01)00884838072312(21)B1XL4C, (01)00884838085176(21)F019V1, (01)00884838085176(21)F07PX3, (01)00884838085176(21)B37DJR, (01)00884838085176(21)F04D7R, (01)00884838086555(21)F025VP, (01)00884838086555(21)F028C7, (01)00884838086555(21)F02F54, (01)00884838086555(21)F02PB1, (01)00884838086555(21)F02RDL, (01)00884838085176(21)F01B7J, (01)00884838085176(21)F07PBC, (01)00884838085176(21)F07RJ2, (01)00884838072312(21)B3H91T, (01)00884838085176(21)F0GMCN, (01)00884838072312(21)B1XL4Q, (01)00884838085176(21)B3085X, (01)00884838085176(21)B3PRB9, (01)00884838085176(21)B3R43M, (01)00884838085176(21)B1QHL2, (01)00884838085176(21)F01LV7, (01)00884838085176(21)F0BMG9, (01)00884838085176(21)F0J0PR, (01)00884838085176(21)B30TL4, (01)00884838086555(21)B2C7W5, (01)00884838086555(21)B2C7WD, (01)00884838086555(21)B2C7YL, (01)00884838086555(21)B2C7ZD, (01)00884838086555(21)B2C7ZF, (01)00884838086555(21)B2C80W, (01)00884838085176(21)B3PKPY, (01)00884838085176(21)B3PL1M, (01)00884838085176(21)B3PR60, (01)00884838085176(21)F0... |
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
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- Delaware
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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.