Recall archive / FDA device enforcement
C10-4ec Transducer Probe — FDA record Z-2351-2025
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
- C10-4ec 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-2351-2025
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. 989605413712, 989605438601, 989605391092; UDI: (01)00884838061507(21)B2KPHY, (01)00884838067837(21)B1JT51, (01)00884838067837(21)B1JTFN, (01)00884838067837(21)B1JTJY, (01)00884838067837(21)B1MT19, (01)00884838067837(21)B1MT9L, (01)00884838067837(21)B1MT9X, (01)00884838067837(21)B1MT9Y, (01)00884838067837(21)B1MTDR, (01)00884838067837(21)B1MTDX, (01)00884838067837(21)B1MTDZ, (01)00884838067837(21)B1MTY9, (01)00884838067837(21)B1N32V, (01)00884838067837(21)B1N33Y, (01)00884838067837(21)B1N340, (01)00884838067837(21)B1N34V, (01)00884838067837(21)B1N352, (01)00884838067837(21)B1N383, (01)00884838067837(21)B1N3CX, (01)00884838067837(21)B1N3FT, (01)00884838067837(21)B1N3MR, (01)00884838067837(21)B1N3MT, (01)00884838067837(21)B1N3V5, (01)00884838067837(21)B1RGK2, (01)00884838067837(21)B1RGL6, (01)00884838067837(21)B1RGL9, (01)00884838067837(21)B1RGR1, (01)00884838067837(21)B1RNJZ, (01)00884838067837(21)B1RNK5, (01)00884838067837(21)B1RNND, (01)00884838067837(21)B1RNQQ, (01)00884838067837(21)B1RNQR, (01)00884838067837(21)B1RP18, (01)00884838067837(21)B1RP19, (01)00884838067837(21)B1RP1C, (01)00884838067837(21)B1RP70, (01)00884838067837(21)B1WQZ1, (01)00884838067837(21)B1WRGN, (01)00884838067837(21)B1WRJC, (01)00884838067837(21)B1WYX1, (01)00884838067837(21)B1WYX3, (01)00884838067837(21)B1WYZ7, (01)00884838067837(21)B1WYZB, (01)00884838067837(21)B1WZ00, (01)00884838067837(21)B1WZ02, (01)00884838067837(21)B1WZ23, (01)00884838067837(21)B1WZ26, (01)00884838067837(21)B1WZ2G, (01)00884838067837(21)B1WZ3H, (01)00884838067837(21)B1WZ56, (01)00884838067837(21)B1WZ7R, (01)00884838067837(21)B1WZBV, (01)00884838067837(21)B1WZFP, (01)00884838067837(21)B1WZFQ, (01)00884838067837(21)B1WZGP, (01)00884838067837(21)B1WZJ7, (01)00884838067837(21)B1WZJ8, (01)00884838067837(21)B1WZJ9, (01)00884838067837(21)B1WZJP, (01)00884838067837(21)B1WZJT, (01)00884838067837(21)B1WZPC, (01)00884838067837(21)B20CFH, (01)00884838067837(21)B20CJG, (01)00884838067837(21)B20CJJ, (01)00884838067837(21)B20CK9, (01)00884838067837(21)B20CKV, (01)00884838067837(21)B20CP7, (01)00884838067837(21)B20D2Y, (01)00884838067837(21)B20D2Z, (01)00884838067837(21)B20D31, (01)00884838067837(21)B20D4W, (01)00884838067837(21)B20D5K, (01)00884838067837(21)B20D5N, (01)00884838067837(21)B20DCQ, (01)00884838067837(21)B20DDX, (01)00884838067837(21)B20LG2, (01)00884838067837(21)B20LGW, (01)00884838067837(21)B20LHZ, (01)00884838067837(21)B20LJT, (01)00884838067837(21)B20LNV, (01)00884838067837(21)B20LTT, (01)00884838067837(21)B20M15, (01)00884838067837(21)B20M9V, (01)00884838067837(21)B20MC8, (01)00884838067837(21)B20MC9, (01)00884838067837(21)B20MK3, (01)00884838067837(21)B20ML6, (01)00884838067837(21)B20MTH, (01)00884838067837(21)B20N36, (01)00884838067837(21)B24K1R, (01)00884838067837(21)B24K1V, (01)00884838067837(21)B24K50, (01)00884838067837(21)B24K6Y, (01)00884838067837(21)B24KBC, (01)00884838067837(21)B24KBF, (01)00884838067837(21)B24KF3, (01)00884838067837(21)B24KMP, (01)00884838067837(21)B24KX2, (01)00884838067837(21)B24KX4, (01)00884838067837(21)B24KYG, (01)00884838067837(21)B24KZM, (01)00884838067837(21)B24KZN, (01)00884838067837(21)B24L55, (01)00884838067837(21)B24LR9, (01)00884838067837(21)B24LV4, (01)00884838067837(21)B24LV5, (01)00884838067837(21)B27KF7, (01)00884838067837(21)B27KF9, (01)00884838067837(21)B27KFB, (01)00884838067837(21)B27KFC, (01)00884838067837(21)B27KGV, (01)00884838067837(21)B27KGW, (01)00884838067837(21)B27KGX, (01)00884838067837(21)B27KHL, (01)00884838067837(21)B27KLY, (01)00884838067837(21)B27KQ0, (01)00884838067837(21)B27KW0, (01)00884838067837(21)B27L5T, (01)00884838067837(21)B27L6Q, (01)00884838067837(21)B27L6R, (01)00884838067837(21)B27L6W, (01)00884838067837(21)B27LB4, (01)00884838067837(21)B27LB6, (01)00884838067837(21)B27LC2, (01)00884838067837(21)B27LCQ, (01)00884838067837(21)B27LCR, (01)00884838067837(21)B27LF2, (01)00884838067837(21)B27LF3, (01)00884838067837(21)B27LF4, (01)00884838067837(21)B27LFJ, (01)00884838067837(21)B27LFK, (01)00884838067837(21)B27LGC, (01)00884838067837(21)B27LGF, (01)00884838067837(21)B27LH0, (01)00884838067837(21)B27LH1, (01)00884838067837(21)B27LHG, (01)00884838067837(21)B27LHQ, (01)00884838067837(21)B27LHV, (01)00884838067837(21)B27LLM, (01)00884838067837(21)B27LLQ, (01)00884838067837(21)B27LLR, (01)00884838067837(21)B27LMP, (01)00884838067837(21)B27LPF, (01)00884838067837(21)B27LQK, (01)00884838067837(21)B27LR4, (01)00884838067837(21)B27LR5, (01)00884838067837(21)B27LW0, (01)00884838067837(21)B27LWH, (01)00884838067837(21)B27LXD, (01)00884838067837(21)B27LXK, (01)00884838067837(21)B27LYK, (01)00884838067837(21)B27LYM, (01)00884838067837(21)B27M3M, (01)00884838067837(21)B27M3P, (01)00884838067837(21)B27M3R, (01)00884838067837(21)B27M5Q, (01)00884838067837(21)B27M75, (01)00884838067837(21)B27M79, (01)00884838067837(21)B27M7B, (01)00884838067837(21)B27MB9, (01)00884838067837(21)B2D4WQ, (01)00884838067837(21)B2D4XZ, (01)00884838067837(21)B2D55Q, (01)00884838067837(21)B2D55R, (01)00884838067837(21)B2D56L, (01)00884838067837(21)B2D56N, (01)00884838067837(21)B2D56P, (01)00884838067837(21)B2D56Q, (01)00884838067837(21)B2D577, (01)00884838067837(21)B2D5BK, (01)00884838067837(21)B2D5CH, (01)00884838067837(21)B2D5DZ, (01)00884838067837(21)B2D5J5, (01)00884838067837(21)B2D5L0, (01)00884838067837(21)B2D5MG, (01)00884838067837(21)B2D9YV, (01)00884838067837(21)B2DGZ4, (01)00884838067837(21)B2DGZ5, (01)00884838067837(21)B2DGZ6, (01)00884838067837(21)B2DH4R, (01)00884838067837(21)B2DH9W, (01)00884838067837(21)B2DHKX, (01)00884838067837(21)B2DHP1, (01)00884838067837(21)B2DHPP, (01)00884838067837(21)B2H1QN, (01)00884838067837(21)B2H252, (01)00884838067837(21)B2H5YP, (01)00884838067837(21)B2H5ZQ, (01)00884838067837(21)B2H647, (01)00884838067837(21)B2H671, (01)00884838067837(21)B2PLM8, (01)00884838067837(21)B2PLXV, (01)00884838067837(21)B2PM1Z, (01)00884838067837(21)B2TQHX, (01)00884838067837(21)B2TQN7, (01)00884838067837(21)B2TQR0, (01)00884838067837(21)B2ZMF5, (01)00884838067837(21)B2ZMF6, (01)00884838067837(21)B2ZMGD, (01)00884838067837(21)B2ZMJ9, (01)00884838067837(21)B2ZMJB, (01)00884838067837(21)B2ZMKN, (01)00884838067837(21)B2ZMLB, (01)00884838067837(21)B2ZMM8, (01)00884838067837(21)B2ZN09, (01)00884838067837(21)B2ZN0V, (01)00884838067837(21)B2ZN0W, (01)00884838067837(21)B2ZN3K, (01)00884838067837(21)B2ZN3L, (01)00884838067837(21)B2ZN5G, (01)00884838067837(21)B2ZN5J, (01)00884838067837(21)B2ZN7P, (01)00884838067837(21)B2ZNC8, (01)00884838067837(21)B32NWZ, (01)00884838067837(21)B32NX7, (01)00884838067837(21)B32NY4, (01)00884838067837(21)B32P15, (01)00884838067837(21)B32P30, (01)00884838067837(21)B32P33, (01)00884838067837(21)B32P62, (01)00884838067837(21)B32P63, (01)00884838067837(21)B32P66, (01)00884838067837(21)B32P67, (01)00884838067837(21)B32P89, (01)00884838067837(21)B32P8K, (01)00884838067837(21)B32P90, (01)00884838067837(21)B32PDN, (01)00884838067837(21)B32PFZ, (01)00884838067837(21)B32PH5, (01)00884838067837(21)B32PHV, (01)00884838067837(21)B32PJ3, (01)00884838067837(21)B32PK0, (01)00884838067837(21)B32PK1, (01)00884838067837(21)B32PKJ, (01)00884838067837(21)B32PTT, (01)00884838067837(21)B32PWL, (01)00884838067837(21)B32PYB, (01)00884838067837(21)B32PYC, (01)00884838067837(21)B35M0N, (01)00884838067837(21)B35M2F, (01)00884838067837(21)B35M2R, (01)00884838067837(21)B35M3Z, (01)00884838067837(21)B35M95, (01)00884838067837(21)B35MDN, (01)00884838067837(21)B35MDQ, (01)00884838067837(21)B35MDR, (01)00884838067837(21)B35MJZ, (01)00884838067837(21)B35MK1, (01)00884838067837(21)B35N0N, (01)00884838067837(21)B35N12, (01)00884838067837(21)B35N13, (01)00884838067837(21)B35N49, (01)00884838067837(21)B35NC1, (01)00884838067837(21)B35NC9, (01)00884838067837(21)B35NCC, (01)00884838067837(21)B35NCD, (01)00884838067837(21)B35NGJ, (01)00884838067837(21)B35NGK, (01)00884838067837(21)B35NL4, (01)00884838067837(21)B35NL6, (01)00884838067837(21)B35NL7, (01)00884838067837(21)B35NL8, (01)00884838067837(21)B35NXG, (01)00884838067837(21)B39TYY, (01)00884838067837(21)B39TZ1, (01)00884838067837(21)B39V06, (01)00884838067837(21)B39V07, (01)00884838067837(21)B39V3Q, (01)00884838067837(21)B39VB5, (01)00884838067837(21)B39VB6, (01)00884838067837(21)B39VDV, (01)00884838067837(21)B39VDW, (01)00884838067837(21)B39VKX, (01)00884838067837(21)B39VKZ, (01)00884838067837(21)B39VT2, (01)00884838067837(21)B39VT7, (01)00884838067837(21)B3FNKD, (01)00884838067837(21)B3FNKF, (01)00884838067837(21)B3FNR0, (01)00884838067837(21)B3FNR6, (01)00884838067837(21)B3FNR7, (01)00884838067837(21)B3FNRC, (01)00884838067837(21)B3FNRR, (01)00884838067837(21)B3FPC6, (01)00884838067837(21)B3FPC9, (01)00884838067837(21)B3FPN1, (01)00884838067837(21)B3FPNR, (01)00884838067837(21)B3HYVJ, (01)00884838067837(21)B3HZ1V, (01)00884838067837(21)B3HZ22, (01)00884838067837(21)B3HZCD, (01)00884838067837(21)B3L81Z, (01)00884838067837(21)B3L82C, (01)00884838067837(21)B3L82F, (01)00884838067837(21)B3L8J5, (01)00884838067837(21)B3L8QG, (01)00884838067837(21)B3L8WP, (01)00884838067837(21)B3L8WR, (01)00884838067837(21)B3L8YQ, (01)00884838067837(21)B3L90J, (01)00884838067837(21)B3L90M, (01)00884838067837(21)B3L92F, (01)00884838067837(21)B3L998, (01)00884838067837(21)B3L999, (01)00884838067837(21)B3L99B, (01)00884838067837(21)B3L9BR, (01)00884838067837(21)B3L9CL, (01)00884838067837(21)B3L9CN, (01)00884838067837(21)B3Q2WJ, (01)00884838067837(21)B3Q30K, (01)00884838067837(21)B3Q30N, (01)00884838067837(21)B3Q36K, (01)00884838067837(21)B3TK6G, (01)00884838067837(21)B3W5HK, (01)00884838067837(21)B3W6NR, (01)00884838067837(21)B3W6NT, (01)00884838067837(21)B3W6R8, (01)00884838067837(21)B3W6RD, (01)00884838067837(21)B3W6VH, (01)00884838067837(21)B3W6VL, (01)00884838067837(21)B3W6WX, (01)00884838067837(21)B3W6XP, (01)00884838067837(21)B3W6XV, (01)00884838067837(21)B3W6Y8, (01)00884838067837(21)B3W6Z2, (01)00884838067837(21)B3W70N, (01)00884838067837(21)B3WWFC, (01)00884838067837(21)B3WWFJ, (01)00884838067837(21)B3WXHN, (01)00884838067837(21)B3WXJG, (01)00884838067837(21)B3WXJJ, (01)00884838067837(21)B3WXMM, (01)00884838067837(21)B3WXMR, (01)00884838067837(21)B3WXXL, (01)00884838067837(21)B3WXXM, (01)00884838067837(21)B3WXXN, (01)00884838067837(21)B3XBDL, (01)00884838067837(21)B3XMZ6, (01)00884838067837(21)B3XMZC, (01)00884838067837(21)B3XNMB, (01)00884838067837(21)B3XNWM, (01)00884838067837(21)B3XPG6, (01)00884838067837(21)B3YNYD, (01)00884838067837(21)B3YNYG, (01)00884838067837(21)B3YNYL, (01)00884838067837(21)B3YNYN, (01)00884838067837(21)B3YP1Y, (01)00884838067837(21)B3YP20, (01)00884838067837(21)B3YP8R, (01)00884838067837(21)B3YP8V, (01)00884838067837(21)B3YPM7, (01)00884838067837(21)B3YPNB, (01)00884838067837(21)B3YPWZ, (01)00884838067837(21)B3YPX2, (01)00884838067837(21)B3YQ29, (01)00884838067837(21)B3YQ2F, (01)00884838067837(21)B3YQGB, (01)00884838067837(21)B3YQNC, (01)00884838067837(21)B3YQNR, (01)00884838067837(21)B3Z607, (01)00884838067837(21)B3Z68N, (01)00884838067837(21)B3Z6W4, (01)00884838067837(21)B3Z764, (01)00884838067837(21)B3Z7CF, (01)00884838067837(21)B3Z7J5, (01)00884838067837(21)B40JG9, (01)00884838067837(21)B40JGB, (01)00884838067837(21)B40JGC, (01)00884838067837(21)B40JK8, (01)00884838067837(21)B40JLF, (01)00884838067837(21)B40KBN, (01)00884838067837(21)B40KH7, (01)00884838067837(21)B40KH8, (01)00884838067837(21)B40KJX, (01)00884838067837(21)B40L34, (01)00884838067837(21)B40L43, (01)00884838067837(21)B40L45, (01)00884838067837(21)B40LC6, (01)00884838067837(21)B40LC8, (01)00884838067837(21)B40LC9, (01)00884838067837(21)B40LCB, (01)00884838067837(21)B40LCC, (01)00884838067837(21)B40ZQR, (01)00884838067837(21)B40ZZQ, (01)00884838067837(21)B4106P, (01)00884838067837(21)B410MT, (01)00884838067837(21)B410XM, (01)00884838067837(21)B410XR, (01)00884838067837(21)F04MGX, (01)00884838067837(21)F04MGY, (01)00884838067837(21)F04NZX, (01)00884838067837(21)F04NZZ, (01)00884838067837(21)F04P00, (01)00884838067837(21)F04P04, (01)00884838067837(21)F04P07, (01)00884838067837(21)F04P09, (01)00884838067837(21)F04P0H, (01)00884838067837(21)F04P0K, ... |
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.