| | Class 3 Device Recall C104ec |  |
| Date Initiated by Firm | July 03, 2025 |
|---|
| Date Posted | August 22, 2025 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2351-2025 |
|---|
| Recall Event ID |
97217 |
| 510(K)Number | K132304 K160807 K163120 K172607 K181485 |
|---|
| Product Classification |
System, imaging, pulsed doppler, ultrasonic - Product Code IYN
|
| Product | C10-4ec Transducer Probe |
|---|
| Code Information |
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, (01)00884838067837(21)F04P0M, (01)00884838067837(21)F04WL9, (01)00884838067837(21)F04WLV, (01)00884838067837(21)F04YZL, (01)00884838067837(21)F04YZM, (01)00884838067837(21)F05518, (01)00884838067837(21)F0551W, (01)00884838067837(21)F05B8D, (01)00884838067837(21)F05B8N, (01)00884838067837(21)F05F2D, (01)00884838067837(21)F05F2M, (01)00884838067837(21)F05HYZ, (01)00884838067837(21)F05HZ0, (01)00884838067837(21)F05LFN, (01)00884838067837(21)F05LFT, (01)00884838067837(21)F05V63, (01)00884838067837(21)F06HXY, (01)00884838067837(21)F06HY0, (01)00884838067837(21)F06HYB, (01)00884838067837(21)F06HYD, (01)00884838067837(21)F06KVB, (01)00884838067837(21)F06KVC, (01)00884838067837(21)F06KVG, (01)00884838067837(21)F06KVJ, (01)00884838067837(21)F06KVK, (01)00884838067837(21)F06KVL, (01)00884838067837(21)F06PHX, (01)00884838067837(21)F06PJ1, (01)00884838067837(21)F06PJ3, (01)00884838067837(21)F06PJ8, (01)00884838067837(21)F06PJB, (01)00884838067837(21)F06RG5, (01)00884838067837(21)F06RG6, (01)00884838067837(21)F06WM7, (01)00884838067837(21)F06WM9, (01)00884838067837(21)F06WMC, (01)00884838067837(21)F06WMD, (01)00884838067837(21)F07367, (01)00884838067837(21)F07BP6, (01)00884838067837(21)F07BP8, (01)00884838067837(21)F07BPG, (01)00884838067837(21)F07BPK, (01)00884838067837(21)F07BPN, (01)00884838067837(21)F07K2J, (01)00884838067837(21)F07K2L, (01)00884838067837(21)F07K2M, (01)00884838067837(21)F07Q0T, (01)00884838067837(21)F07Q0V, (01)00884838067837(21)F07Q0X, (01)00884838067837(21)F07Q19, (01)00884838067837(21)F07Q1B, (01)00884838067837(21)F07W0V, (01)00884838067837(21)F07W12, (01)00884838067837(21)F07Z43, (01)00884838067837(21)F082BX, (01)00884838067837(21)F082C6, (01)00884838067837(21)F086L4, (01)00884838067837(21)F08BH2, (01)00884838067837(21)F08BH6, (01)00884838067837(21)F08BH7, (01)00884838067837(21)F08CWB, (01)00884838067837(21)F08CWP, (01)00884838067837(21)F08CWR, (01)00884838067837(21)F08CWV, (01)00884838067837(21)F08FWG, (01)00884838067837(21)F08FWH, (01)00884838067837(21)F08FWK, (01)00884838067837(21)F08FWQ, (01)00884838067837(21)F08FWW, (01)00884838067837(21)F08FWY, (01)00884838067837(21)F08FX0, (01)00884838067837(21)F08MJC, (01)00884838067837(21)F08MJG, (01)00884838067837(21)F08MJL, (01)00884838067837(21)F08MJN, (01)00884838067837(21)F08MJQ, (01)00884838067837(21)F08QRF, (01)00884838067837(21)F08QRM, (01)00884838067837(21)F08QRN, (01)00884838067837(21)F08QRV, (01)00884838067837(21)F08W29, (01)00884838067837(21)F08W2K, (01)00884838067837(21)F092TB, (01)00884838067837(21)F092TJ, (01)00884838067837(21)F0948J, (01)00884838067837(21)F0948P, (01)00884838067837(21)F0948Q, (01)00884838067837(21)F0948X, (01)00884838067837(21)F09493, (01)00884838067837(21)F096FC, (01)00884838067837(21)F096FG, (01)00884838067837(21)F096FH, (01)00884838067837(21)F096FR, (01)00884838067837(21)F096FX, (01)00884838067837(21)F098WW, (01)00884838067837(21)F09DGW, (01)00884838067837(21)F09DGY, (01)00884838067837(21)F09DH0, (01)00884838067837(21)F09DHH, (01)00884838067837(21)F09L4X, (01)00884838067837(21)F09L54, (01)00884838067837(21)F09L55, (01)00884838067837(21)F09L5B, (01)00884838067837(21)F0CL5H, (01)00884838067837(21)F0CL5L, (01)00884838067837(21)F0CTZD, (01)00884838067837(21)F0CTZG, (01)00884838067837(21)F0DP04, (01)00884838067837(21)F0DRG9, (01)00884838067837(21)F0DRGB, (01)00884838067837(21)F0DRGY, (01)00884838067837(21)F0DRH0, (01)00884838067837(21)F0DVZD, (01)00884838067837(21)F0DVZK, (01)00884838067837(21)F0DVZM, (01)00884838067837(21)F0DZWP, (01)00884838067837(21)F0F3QQ, (01)00884838067837(21)F0F3QR, (01)00884838067837(21)F0F3QV, (01)00884838067837(21)F0F3R0, (01)00884838067837(21)F0F3R2, (01)00884838067837(21)F0F5VY, (01)00884838067837(21)F0F5W3, (01)00884838067837(21)F0FTR8, (01)00884838067837(21)F0FWVM, (01)00884838067837(21)F0G0H8, (01)00884838067837(21)F0G0HC, (01)00884838067837(21)F0G81J, (01)00884838067837(21)F0G81N, (01)00884838067837(21)F0GCJ3, (01)00884838067837(21)F0GCJ7, (01)00884838067837(21)F0GCJ9, (01)00884838067837(21)F0GJ2C, (01)00884838067837(21)F0GJ2F, (01)00884838067837(21)F0GJ2N, (01)00884838067837(21)F0GM0H, (01)00884838067837(21)F0H48B, (01)00884838067837(21)F0H48K, (01)00884838067837(21)F0H48L, (01)00884838067837(21)F0H48R, (01)00884838067837(21)F0HD2D, (01)00884838067837(21)F0HNVM, (01)00884838067837(21)F0HNVT, (01)00884838067837(21)F0HVCH, (01)00884838067837(21)F0HWLM, (01)00884838067837(21)F0HWLN, (01)00884838067837(21)F0HWMC, (01)00884838067837(21)F0HWMG, (01)00884838067837(21)F0HWML, (01)00884838067837(21)F0J1TR, (01)00884838067837(21)F0J4DF, (01)00884838067837(21)F0J4DH, (01)00884838067837(21)F0J9LN, (01)00884838067837(21)F0J9LP, (01)00884838067837(21)F0J9LQ, (01)00884838067837(21)F0JDNZ, (01)00884838067837(21)F0JG8H, (01)00884838067837(21)F0JG8K, (01)00884838067837(21)F0JKT5, (01)00884838067837(21)F0JKT7, (01)00884838067837(21)F0JRPF, (01)00884838067837(21)F0JTJT, 010088483806783721B35ND8, 010088483806783721B3TKRV, 010088483806783721B3XB08, 010088483806783721B3XB0C, 010088483806783721B3XNKC, 010088483806783721B3XNKG, 010088483806783721B3XNT4, 010088483806783721B3XNV6, 010088483806783721B3XP0B, 010088483806783721B3XP25, 010088483806783721B3XPBL, 010088483806783721B3XPG4, 010088483806783721B3XPG8, 010088483806783721B3XPG9, 010088483806783721F0FTRJ, 010088483806783721F0FTRQ, 010088483806783721F0FWVL, 010088483806783721F0FWVN, 010088483806783721F0G0HD, 010088483806783721F0G0HH, 010088483806783721F0G5K9, 010088483806783721F0G5KG, 010088483806783721F0G81G, 010088483806783721F0G81M, 010088483806783721F0G81Q, 010088483806783721F0GCJ1, 010088483806783721F0GCJ2, 010088483806783721F0GFHQ, 010088483806783721F0GFHT; Serial No. Serial Number, B1MT9L, B20D4W, B2ZMM8, B1JTLP, F0DRG9, F0DZWN, F07BPK, F07K2J, B32P33, F08W2K, F0G0HH, F0DRGB, F07Q0V, B32P15, B32P30, B1MT9X, B39VKZ, B3W6R8, B3W6RD, B3W6XP, B20N36, B1JT56, B1DBKG, B3Q36K, B3Z764, B3Z7J5, B35NL7, B27LGF, B27LQK, B27LR4, B19MZX, B35MDR, B35MJZ, B1WRJC, B20M9V, F05518, B1WYZ7, B32P8K, F0F5W3, B24LV5, B2DGZ6, B27LCQ, B27LF2, B27LF4, B27LFJ, B27LHV, B27LMP, B27LXD, B27LXK, B27LYK, B2D5CH, B2PLXV, B1DB5C, B3Q30N, B1RGR1, B2ZN09, B3FNKD, B3XMZC, B3Z6W4, F07Z43, B3XNKC, F0G0HC, B3FNKF, B1WRGN, B27LPF, B27KGX, F0H48K, B3YNYD, B3YP20, B19M3M, B24KZM, B27KGW, B27LCR, B27LF3, F0551W, F05B8D, B3Z68N, F086L4, F08BH6, F08CWV, F08FWQ, F08FX0, F08MJL, F07BP6, B20D5K, B20D5N, B2DHP1, B1WYX1, B1WYX3, B27LB6, B27LHG, B27LLQ, B2D5J5, B2D5MG, B2D9YV, B20MTH, F06WM9, B3L8QG, F0GCJ2, B1N3MT, F08FWK, B20DCQ, B3YP8R, F07Q19, F0HVCH, F06WMD, B3W6NT, B35M95, B35MDQ, B1WZJ8, B1WZJT, B35N13, B3L8WP, B3L8WR, B3L8YQ, B3L90M, B3L998, B3L99B, B39V3Q, B32PWL, B2THWN, B2PM1Y, F0H48B, F0J4DF, B1492J, B1JTQ3, B32P62, B3W6Z2, B3WXMM, F06PJB, B1DBVV, B2H5YM, B3YQGB, B2ZMLB, B1RP19, B20LJT, B20LNV, B3WXJG, F06PJ1, B27LH0, B37LH0, B27M3M, B2D5DZ, B3YNYL, B27L5T, B2D577, B3WXJJ, B35N49, B35NC1, B35NGJ, B35NGK, B35NL4, B35NL6, B35NL8, B39TYY, B39V06, B39V07, F0CL5H, F0GJ2C, B35MDN, B35NC9, B35NCD, B32P66, B32P90, B32PHV, B32PJ3, B32PK0, B32PKJ, B32PTT, B32PYC, B3FNRC, F06KVJ, F0GCJ3, F07W0V, B2ZMF5, B2ZMF6, B2ZMGD, F0HWMG, B19MDN, B19MLQ, B14BFH, B19MCW, B19NFT, F06PJ8, B39VKX, B39VDW, B3L90J, F08MJN, F08CWB, B3Q2WJ, B39VT2, F06RG6, F07367, B1JTL6, B2H5YP, B24KX4, B27KF7, B27KHL, B32NWZ, B3WXHN, F0DRH0, F0FTRQ, F0FWVL, F0FWVN, F0G5K9, F0G81G, B14BFF, F0FQJ4, F0FWVK, F0G81H, F0G81R, F08MJG, B40KH7, B1N383, B20CJG, B2DGZ5, B1RNQQ, F05F2M, B3FPC6, B3FPNR, F06KVB, F0GFHT, B27LGC, B3FPC9, B27KGV, B1WZGP, B20CK9, B3FNR6, B3WWFC, B3YQNR, B2PLM8, B27KLY, B40LC6, B40LCB, F06PJ3, B24K1V, F06KVG, F0F3R0, F0F3R2, B2TPNR, F0JDNZ, F0J9LP, F0JG8H, B3WXXN, B24LV4, B1MTYT, B2ZN7P, F09L5B, B1WZ00, B35M2R, B35MK1, B19M9P, B19MV8, B40LCC, B32PFZ, B32PK1, B20CFH, B24LR9, B2TQHX, B3L82F, B3YQ29, B3FNR0, F08FWY, F0F5VY, F0HWLN, B1WZBV, B27LB4, B2ZN5G, B32P67, B3L81Z, B1RNJZ, B20MK3, B3XNWM, F06HXY, B3XPG8, B1WZ3H, B20ML6, B40L43, B40L45, F0948P, F05V63, F06HYD, F06KVK, F096FH, F06HY0, B3FNR7, B3WXMR, F0HWML, B1RNQR, B20DDX, B3W6WX, B19MXQ, B1DBC3, B1WZ2G, B20LG2, B27LH1, F0FTRJ, B3XPBL, B32PYB, B40KJX, F092TJ, B1RNND, B2D55Q, F06RG5, B3XPG6, F07K2M, B3XMZ6, B0PBWY, B24KMP, B27L6R, B3W70N, B27M79, B3YQ2F, B39VB6, F06WMC, B24K50, B1RP70, B3W5HK, B32P63, B3YPM7, B27LHQ, B32NX7, F092TB, F09493, F096FR, F098WW, B2ZNC8, B40JLF, B1N3V5, F06PHX, F0CL5L, B3XPG9, B3YNYN, B3YPWZ, B3HYVJ, B35M0N, B3W6VH, F096FG, B1JTY5, B2H671, B39VT7, B3XBDL, B3Z607, B19NFZ, B3W6VL, B20D31, B3L82C, B2H265, B2DHP0, B2DH4R, B2DHPP, B1JTJY, B27L6W, B3Z7CF, F0G5KG, B20D2Z, F0CTZD, B35NXG, B3YNYG, B3YP8V, B1DBNY, B2D5BK, B3W6XV, B3W6NR, F0DVZD, F0DVZ5, B24K6Y, B24KBC, B24KYG, B1WZ02, B2D4XZ, B27M3P, B2DHKX, F05LFT, B20CJJ, B27L6Q, B40JGB, B40KH8, F082BX, F0GJ2N, F0G81Q, B3TK6G, F05LFN, B24L55, F0GJ2F, B39VB5, F05HYZ, F08QRV, F09DH0, B35M2F, F05B8N, F07Q0X, F07Q1B, B27MB9, F07BP8, F05LFP, F05LFV, B1N3MR, B20M15, B27LC2, B3XNMB, B3XNKG, F06WM7, F0DVZK, B1DBVT, F0JG8K, B3FPN1, B19MXM, B39TZ1, B1DBC2, B3XP25, B1MTDX, B1RP1C, B24KZN, F0JKT5, F0JKT7, F0JRPF, F0JTJT, B32PDN, F0G81M, B27M3R, B27M75, B2D4WQ, B2D5L0, B27M5Q, B2D55R, B2D56N, B40LC8, B1JT51, F06KVL, B1WQZ1, B24K1R, B24KBF, B27KFB, B27KQ0, F0DVZM, B20LHZ, B35M3Z, B1JTP8, F0FTR8, B3L999, F08BH2, F0GCJ1, B27LWH, B27LFK, B27LLR, B27LR5, B27LW0, B27LYM, B2H647, B2PM1Z, B1RP18, B1RGL9, B1MTYB, B2TQN7, B1RNK5, B19M02, B2H252, B3FNRR, B20MC9, B1JTFN, F07BPG, F09L4X, B2D56L, B2D56Q, B1MT19, B20CKV, B20LTT, F07BPN, B1JTNX, B1DBLX, B3HZ1V, B2TQR0, F0HNVM, B1DBTY, B2H5ZQ, B2ZN3K, B35N12, F082C6, F08MJC, F0948J, B39VDV, B1JTNW, B1JTRX, B3L9CN, F0HWMC, F08QRF, B3L92F, F08QRN, F0F3QR, F05F2D, B1WZ56, B1WZ26, B1MT9Y, B20MC8, B40JGC, F09L55, B40LC9, B32P89, B40JG9, B1WYZB, B149B5, F096FX, F0H48R, B1MTDZ, B1MTY9, B1N32V, B1N33Y, B1N340, B1N34V, B1N352, B1N3FT, B27KF9, B27KFC, B32PH5, B1JT54, B32NY4, F08FWG, F08FWW, F09DGW, F09DHH, F09L54, B27M7B, B3L8J5, B2H1QN, F06KVC, F08FWH, F0948X, F0G0H8, F0GCJ9, B27LLM, B40L34, B3YQNC, B3WXXL, B3WXXM, B35ND8, B3TKRV, B3XB0C, B3XNT4, B3XNV6, B3XP0B, B1JTHZ, F05HZ0, B19NLP, F0DRGY, F0HNVT, B35NCC, B3YP1Y, F08QRM, F0FWVM, F0GFHQ, F07W12, B20CP7, B1WZFP, B1WZFQ, B1WZJ7, B1WZJP, B1WZPC, F0HD2D, B1WZJ9, B1WZ23, B1MTDR, F07K2L, F07Q0T, B3HZCD, B20D2Y, B40KBN, B1WZ7R, B1DBDT, B24KF3, B20LGW, B3W6Y8, B1N3CX, B2DGZ4, B2D56P, B3XB08, B24KX2, F09DGY, B3HZ22, B2ZMJ9, B2ZMJB, B2ZMKN, B2ZN0V, B2ZN0W, F0GM0H, B35N0N, B3YPX2, F0H48L, B3L9CL, B3Q30K, B2ZN5J, F06HYB, F08CWP, F08CWR, B27KW0, F08BH7, B3YPNB, B3XPG4, F0948Q, F096FC, F0CTZG, B2DH9W, B2ZN3L, F0G81N, B19MXK, F0G81J, F0GCJ7, B2PLDR, B2PLDN, B3L9BR, B1RGK2, F0DP04, F0F3QV, F0F3QQ, F0HWLM, F0J4DH, F0J9LN, F0J9LQ, F0DZWP, F0G0HD, B1RGL6, B40ZQR, B40ZZQ, B4106P, B410MT, B410XM, B410XR, F04MGX, F04MGY, F04NZX, F04NZZ, F04P00, F04P04, F04P07, F04P09, F04P0H, F04P0K, F04P0M, F04WL9, F04WLV, F04YZL, F04YZM, B3WWFJ, B40JK8, F0J1TR, F08MJQ, F08W29. |
Recalling Firm/
Manufacturer |
Philips Ultrasound, Inc
1 Echo Dr
Reedsville PA 17084-8603
|
| For Additional Information Contact | Philips Customer Care Solutions Center
1-800-722-9377 |
|---|
Manufacturer Reason
for Recall | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
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FDA Determined
Cause 2 | Device Design |
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| Action | An URGENT Medical Device Correction Notice, dated 7/3/25, was mailed to consignees. This notice instructs consignees to locate all Philips Ultrasound transducers in their facility and enter their serial numbers into https://www.transducer.philips.com to obtain the manufacturing certificate for each of their devices. This certificate should be retained with its system documentation. Using the manufacturing certificate consignees are to calculate the useful life of their device. The expected useful life for Transesophageal transducers, X-Matrix transducers, and Lumify transducers is 5 years; The expected useful life for Endocavity transducers and Transcutaneous transducers is 7 years. If a transducer has exceeded its useful life, consignees are instructed to conduct transducer performance tests or contact Philips for guidance. Consignees are asked to complete and return the provided response form and circulate the recall notification to device users for their awareness. Consignees with any questions can contact Philips Customer Care Solutions Center at 1-800-722-9377. |
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| Quantity in Commerce | 171,322 units |
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| Distribution | US Nationwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = IYN
510(K)s with Product Code = IYN
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