Recall archive / FDA device enforcement
mC12-3 Transducer Probe — FDA record Z-2383-2025
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
- mC12-3 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-2383-2025
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. 989605495721; UDI: (01)00884838093935(21)F0FKJ7, 010088483809393521F0FRHZ, (01)00884838093935(21)B3XYRY, (01)00884838093935(21)B4161X, (01)00884838093935(21)F07K8J, (01)00884838093935(21)F0JTY0, (01)00884838093935(21)F04YTZ, (01)00884838093935(21)F0550K, (01)00884838093935(21)F094Y9, (01)00884838093935(21)F0GJC9, (01)00884838093935(21)B3XZRM, (01)00884838093935(21)F0KC6Y, (01)00884838093935(21)F0HP38, (01)00884838093935(21)F0F164, (01)00884838093935(21)F0KND1, (01)00884838093935(21)F04YV6, 010088483809393521B3Y0KC, (01)00884838093935(21)F0JZQ6, (01)00884838093935(21)F0JZQ7, (01)00884838093935(21)B3XZ5Q, (01)00884838093935(21)F07WW2, (01)00884838093935(21)F07WW9, (01)00884838093935(21)F07WWF, (01)00884838093935(21)F07WWJ, (01)00884838093935(21)F07WWL, (01)00884838093935(21)F07WWN, (01)00884838093935(21)F07WWP, (01)00884838093935(21)F07WWQ, (01)00884838093935(21)F07ZZ0, (01)00884838093935(21)F081V3, (01)00884838093935(21)F08H3V, (01)00884838093935(21)F05FK6, (01)00884838093935(21)F06GWZ, (01)00884838093935(21)F07D0C, (01)00884838093935(21)F0B94X, (01)00884838093935(21)F0GJCR, (01)00884838093935(21)B3FKZJ, (01)00884838093935(21)B3FKZN, (01)00884838093935(21)F0LC8N, (01)00884838093935(21)F04QBB, (01)00884838093935(21)F04V3M, (01)00884838093935(21)F04V3Q, (01)00884838093935(21)F04XDN, (01)00884838093935(21)F04XF1, (01)00884838093935(21)F04XF6, (01)00884838093935(21)F06XQF, (01)00884838093935(21)F0F4BF, (01)00884838093935(21)F0F4BN, (01)00884838093935(21)F0F7ZJ, (01)00884838093935(21)F0FKK9, 010088483809393521B3Y0KG, (01)00884838093935(21)F06XQV, (01)00884838093935(21)F06KRF, (01)00884838093935(21)F0JPPM, (01)00884838093935(21)F0K7LQ, (01)00884838093935(21)B3FLBF, (01)00884838093935(21)B3FLDJ, 010088483809393521F0G346, (01)00884838093935(21)B3XZRN, (01)00884838093935(21)B3XZY3, (01)00884838093935(21)B3XZ1X, (01)00884838093935(21)B41GND, (01)00884838093935(21)F0KC6Z, (01)00884838093935(21)B3FLFY, (01)00884838093935(21)F04QBW, (01)00884838093935(21)F0JL20, (01)00884838093935(21)B3FL3H, 010088483809393521B3Y0LX, (01)00884838093935(21)B3FLML, (01)00884838093935(21)F04YV4, (01)00884838093935(21)F094F4, (01)00884838093935(21)F09BZY, (01)00884838093935(21)B3FMGT, (01)00884838093935(21)B3FMGV, (01)00884838093935(21)F0715Y, (01)00884838093935(21)F07166, (01)00884838093935(21)F07D0G, (01)00884838093935(21)F08H3P, (01)00884838093935(21)F0JWZ9, (01)00884838093935(21)F09GFP, (01)00884838093935(21)B3FKZM, (01)00884838093935(21)B3FL0R, (01)00884838093935(21)B3FLT4, (01)00884838093935(21)F08R38, (01)00884838093935(21)B41GNT, 010088483809393521B3FM7L, 010088483809393521B3Y0LB, 010088483809393521B3Y0LH, 010088483809393521B3Y0LJ, (01)00884838093935(21)F07K85, (01)00884838093935(21)F0JPPL, (01)00884838093935(21)F0JRVG, (01)00884838093935(21)F0JZQ0, (01)00884838093935(21)B3FL5X, (01)00884838093935(21)B3L524, (01)00884838093935(21)F04QB9, (01)00884838093935(21)F04QBC, (01)00884838093935(21)F07RY3, (01)00884838093935(21)F09BZW, (01)00884838093935(21)F06GWR, 010088483809393521F0FP12, (01)00884838093935(21)F04QC0, (01)00884838093935(21)B3FLXG, (01)00884838093935(21)B3FLXP, (01)00884838093935(21)B3FLXR, (01)00884838093935(21)B3FLXT, (01)00884838093935(21)B3FMFF, (01)00884838093935(21)B3XZMQ, (01)00884838093935(21)B3XZXP, (01)00884838093935(21)F07GKY, (01)00884838093935(21)F07RY7, (01)00884838093935(21)F07RYB, (01)00884838093935(21)F07WWY, (01)00884838093935(21)F0842B, (01)00884838093935(21)F098FT, (01)00884838093935(21)F0HFNF, (01)00884838093935(21)F0K7LM, (01)00884838093935(21)F0K7LN, (01)00884838093935(21)F0K7LP, (01)00884838093935(21)F0K7LR, (01)00884838093935(21)F0K7M7, (01)00884838093935(21)B3FLMX, 010088483809393521F0FP13, (01)00884838093935(21)F04QBK, (01)00884838093935(21)F06LJT, (01)00884838093935(21)F06TG7, (01)00884838093935(21)F06XQZ, (01)00884838093935(21)F0715M, (01)00884838093935(21)F07ZZ5, (01)00884838093935(21)F07ZZ6, (01)00884838093935(21)F08H3M, (01)00884838093935(21)F08MG7, 010088483809393521F0FRJ0, (01)00884838093935(21)F0HP34, (01)00884838093935(21)F0GJCQ, (01)00884838093935(21)F0550W, (01)00884838093935(21)F0596C, (01)00884838093935(21)F094F3, (01)00884838093935(21)F0JRVD, (01)00884838093935(21)B3Y038, (01)00884838093935(21)B3Y052, (01)00884838093935(21)B3Y0GL, (01)00884838093935(21)F0JDZK, (01)00884838093935(21)F0JH08, (01)00884838093935(21)F0JH0G, (01)00884838093935(21)F0JL28, (01)00884838093935(21)F04QBT, (01)00884838093935(21)F04V3C, (01)00884838093935(21)B3Y0GP, (01)00884838093935(21)B3FLK9, (01)00884838093935(21)F0596V, (01)00884838093935(21)F05BQR, 010088483809393521B3FM7D, (01)00884838093935(21)F0K7M4, (01)00884838093935(21)B3FLTN, (01)00884838093935(21)B3FLRX, (01)00884838093935(21)F0841G, (01)00884838093935(21)F0KQJK, (01)00884838093935(21)F09JNR, (01)00884838093935(21)F09PVK, (01)00884838093935(21)F0F4C7, (01)00884838093935(21)B3FL3G, (01)00884838093935(21)B3FL3J, (01)00884838093935(21)F07GL0, (01)00884838093935(21)B3FLFQ, 010088483809393521F0GJC5, (01)00884838093935(21)B3Y02Y, (01)00884838093935(21)B3Y050, 010088483809393521F0FP0Q, (01)00884838093935(21)F06KR9, 010088483809393521F0GFQ2, (01)00884838093935(21)B3FMBQ, (01)00884838093935(21)F081VL, (01)00884838093935(21)F0841K, (01)00884838093935(21)F09BZT, (01)00884838093935(21)B3FLT3, 010088483809393521B3FM57, 010088483809393521B3FM7T, (01)00884838093935(21)F06GWX, (01)00884838093935(21)F0KNDF, (01)00884838093935(21)F08MG9, (01)00884838093935(21)F0JTXP, (01)00884838093935(21)F07GKG, (01)00884838093935(21)F07RY8, (01)00884838093935(21)F0GR37, (01)00884838093935(21)F0HV5V, (01)00884838093935(21)B3FL47, (01)00884838093935(21)B41625, (01)00884838093935(21)B41629, (01)00884838093935(21)B4162C, (01)00884838093935(21)F0KC74, (01)00884838093935(21)B3Y05C, (01)00884838093935(21)B3XZ5B, (01)00884838093935(21)F05FK8, (01)00884838093935(21)F07D0J, (01)00884838093935(21)F07D0K, (01)00884838093935(21)F08LD9, (01)00884838093935(21)F08MH1, (01)00884838093935(21)B3FLKD, (01)00884838093935(21)F07K8T, (01)00884838093935(21)F081VJ, (01)00884838093935(21)F094Y3, (01)00884838093935(21)F07WWK, (01)00884838093935(21)B3FLDL, (01)00884838093935(21)B3FLDN, (01)00884838093935(21)B3FLDQ, (01)00884838093935(21)F0JZQB, (01)00884838093935(21)F0K1LL, (01)00884838093935(21)F07GKZ, (01)00884838093935(21)F07WWV, (01)00884838093935(21)F07ZZL, (01)00884838093935(21)F07CZZ, (01)00884838093935(21)B3XZVJ, (01)00884838093935(21)B3XZXV, (01)00884838093935(21)F04MY9, (01)00884838093935(21)F04QBM, (01)00884838093935(21)F07K86, (01)00884838093935(21)F04QBH, (01)00884838093935(21)B3FLWH, (01)00884838093935(21)B3FLX6, (01)00884838093935(21)B3FLX9, (01)00884838093935(21)B3FLXB, (01)00884838093935(21)F09PVB, 010088483809393521B3Y0JZ, (01)00884838093935(21)F04XFF, (01)00884838093935(21)B41626, (01)00884838093935(21)B3FMKX, (01)00884838093935(21)F06KRD, (01)00884838093935(21)B3FL5W, (01)00884838093935(21)B3XYRX, (01)00884838093935(21)B41GNX, (01)00884838093935(21)F07ZZD, (01)00884838093935(21)F0GKW6, (01)00884838093935(21)F0GKW7, (01)00884838093935(21)F09Z34, (01)00884838093935(21)B411HH, (01)00884838093935(21)B41GNC, (01)00884838093935(21)F0K1LR, (01)00884838093935(21)F0J4HF, (01)00884838093935(21)F0F7ZL, (01)00884838093935(21)F0L9RY, (01)00884838093935(21)B3XYRN, (01)00884838093935(21)F0GM7P, (01)00884838093935(21)F07ZYY, 010088483809393521F0FQTL, (01)00884838093935(21)F0FKK8, (01)00884838093935(21)F0KR3Z, 010088483809393521B3FM7V, (01)00884838093935(21)F0JTXV, (01)00884838093935(21)F08R3N, (01)00884838093935(21)B3FM9R, (01)00884838093935(21)F06PPC, (01)00884838093935(21)F0JWYZ, (01)00884838093935(21)B3FL0W, (01)00884838093935(21)B3FL13, (01)00884838093935(21)B3FL21, (01)00884838093935(21)B3FL44, (01)00884838093935(21)B3FL6B, (01)00884838093935(21)B3FMDC, (01)00884838093935(21)B3XZ4J, (01)00884838093935(21)B3XZ59, (01)00884838093935(21)B3XZHC, (01)00884838093935(21)F0550F, (01)00884838093935(21)F0550J, (01)00884838093935(21)F06LJD, (01)00884838093935(21)F06LJZ, (01)00884838093935(21)F06PPB, (01)00884838093935(21)F0F7ZM, (01)00884838093935(21)F0KV7N, (01)00884838093935(21)F0KV7Q, (01)00884838093935(21)F0JTXN, (01)00884838093935(21)F07WWX, (01)00884838093935(21)F0HX2P, (01)00884838093935(21)F06XQ7, (01)00884838093935(21)F06XQB, (01)00884838093935(21)F06XQJ, (01)00884838093935(21)F081V2, (01)00884838093935(21)F0JTXY, (01)00884838093935(21)F0JTXZ, (01)00884838093935(21)F05BRB, (01)00884838093935(21)F06TG5, (01)00884838093935(21)B3L51H, (01)00884838093935(21)F0K1LM, (01)00884838093935(21)B3FL49, (01)00884838093935(21)B3FLD3, (01)00884838093935(21)F0GW61, (01)00884838093935(21)F06LJP, (01)00884838093935(21)F0JL23, (01)00884838093935(21)F0JL2B, (01)00884838093935(21)F0JWZ5, (01)00884838093935(21)F0JZQ3, (01)00884838093935(21)F0JZQ4, (01)00884838093935(21)F0JZQ5, (01)00884838093935(21)B3FLBC, (01)00884838093935(21)F09FZ3, (01)00884838093935(21)F0GJCC, (01)00884838093935(21)B3L50P, (01)00884838093935(21)F09FZ1, (01)00884838093935(21)B3FMD3, (01)00884838093935(21)B3XZHG, (01)00884838093935(21)F09D24, (01)00884838093935(21)F08LDP, (01)00884838093935(21)F09GG2, (01)00884838093935(21)F0GR33, (01)00884838093935(21)F0GW64, (01)00884838093935(21)B3Y0GK, (01)00884838093935(21)F0596Y, (01)00884838093935(21)F0KND4, (01)00884838093935(21)F06TFM, (01)00884838093935(21)B3FLTW, (01)00884838093935(21)F06XQ6, (01)00884838093935(21)F07160, (01)00884838093935(21)F04XDW, (01)00884838093935(21)F09MCG, (01)00884838093935(21)F0KK1F, (01)00884838093935(21)B3FM9W, (01)00884838093935(21)B3FMG7, (01)00884838093935(21)B3FMH5, (01)00884838093935(21)B3L507, (01)00884838093935(21)B3LBBK, (01)00884838093935(21)B3LBDC, (01)00884838093935(21)B3XZYH, (01)00884838093935(21)F04V3D, (01)00884838093935(21)F0B944, (01)00884838093935(21)F07D05, (01)00884838093935(21)F07RXZ, (01)00884838093935(21)F07RYH, (01)00884838093935(21)F07WW5, (01)00884838093935(21)F09PVL, (01)00884838093935(21)B3FL0M, (01)00884838093935(21)F07RYY, (01)00884838093935(21)F0HYTG, (01)00884838093935(21)B3XZ4F, (01)00884838093935(21)B3FLMG, (01)00884838093935(21)F0GR3J, (01)00884838093935(21)F04QBR, (01)00884838093935(21)F0596K, (01)00884838093935(21)F04YTL, (01)00884838093935(21)B3LBFP, (01)00884838093935(21)F0FKK0, (01)00884838093935(21)F0FP16, (01)00884838093935(21)F0B94R, (01)00884838093935(21)B3Y0GG, 010088483809393521B3Y0K1, (01)00884838093935(21)F0GCP3, (01)00884838093935(21)F0GFPZ, (01)00884838093935(21)B3FMKY, (01)00884838093935(21)F06XQM, (01)00884838093935(21)F094XW, (01)00884838093935(21)B3Y01W, (01)00884838093935(21)B41GNP, (01)00884838093935(21)B3XZT0, (01)00884838093935(21)B3XZXY, (01)00884838093935(21)F06KR7, (01)00884838093935(21)B3FLYF, (01)00884838093935(21)F0L7Q5, 010088483809393521F0GJC7, (01)00884838093935(21)F04YTH, (01)00884838093935(21)F05GQG, (01)00884838093935(21)F07D0M, (01)00884838093935(21)F06GWM, (01)00884838093935(21)F04QBF, (01)00884838093935(21)B3FLMP, (01)00884838093935(21)B3XZXJ, (01)00884838093935(21)F07P25, (01)00884838093935(21)F0L40H, 010088483809393521B3Y0KJ, 010088483809393521F0GCP5, (01)00884838093935(21)F0JTY1, (01)00884838093935(21)F0JZQ2, (01)00884838093935(21)F0L7PZ, (01)00884838093935(21)F07P28, (01)00884838093935(21)F05V8X, (01)00884838093935(21)F04MYB, (01)00884838093935(21)B3Y0GR, (01)00884838093935(21)B4161Q, (01)00884838093935(21)F04MXZ, (01)00884838093935(21)F05GQB, (01)00884838093935(21)F0841V, (01)00884838093935(21)F0FP15, (01)00884838093935(21)F0K7M0, (01)00884838093935(21)B3XZRJ, (01)00884838093935(21)B4161P, (01)00884838093935(21)B4161Y, (01)00884838093935(21)F0B948, (01)00884838093935(21)F05GQ9, (01)00884838093935(21)F05GQN, (01)00884838093935(21)B3XYRJ, 010088483809393521B3Y0K5, (01)00884838093935(21)B3XYRR, (01)00884838093935(21)B3FLTG, (01)00884838093935(21)F06TFJ, (01)00884838093935(21)F07164, (01)00884838093935(21)F0JWZ7, (01)00884838093935(21)F0JWZC, (01)00884838093935(21)B3XZRY, (01)00884838093935(21)B3FLRT, (01)00884838093935(21)F09Z2X, (01)00884838093935(21)F09Z36, (01)00884838093935(21)F09Z3D, (01)00884838093935(21)B3FLBT, (01)00884838093935(21)B41GNL, (01)00884838... |
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.