Device product
3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
Z-2517-2023
Product summary
- Event
- Event 92761
- Status
- Completed
- Classification
- Class II
- Quantity
- 449
- Official record key
device-enforcement:Z-2517-2023
Official wording
Reason: Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, and electric shock if the built-in safety measures to prevent electric were to also fail.
Code information: UDI-DI:00884838061545, Serial Numbers: F07VBZ, F083JP, F086Z5, F088QC, F08JPF, F08K4H, F08VLP, F08VLY, F08W1C, F08W1D, F08W1J, F08W1K, F08W1L, F08W1M, F08W1Q, F08WXP, F08WXY, F08WZY, F08X01, F08X02, F08X03, F08X04, F08Y2T, F08ZR3, F08ZR4, F08ZR5, F092BQ, F092BR, F092BV, F097QQ, F097QV, F097QW, F09BTB, F09BTC, F09BTD, F09BTG, F09BTH, F09BTN, F09BTP, F09C1G, F09C1H, F09C1L, F09C1M, F09F3R, F09F3T, F09F3V, F09F3X, F09F3Y, F09F3Z, F09F40, F09F41, F09F42, F09F43, F09F45, F09F48, F09F49, F09F4C, F09F4D, F09F4F, F09F4G, F09F4H, F09JT0, F09JT2, F09JT3, F09MH4, F09MH5, F09MH6, F09MH7, F09MH8, F09MH9, F09MHB, F09MHC, F09MHG, F09MHH, F09MHK, F09MHL, F09MHM, F09MHN, F09MHP, F09N4J, F09N4K, F09N4M, F09N4N, F09N4P, F09NLM, F09NLN, F09NLP, F09NLT, F09V25, F09V26, F09V27, F09V28, F09V29, F09V2C, F09V2D, F09V2F, F09V2G, F09V2H, F09V2J, F09VH6, F09VH7, F09VH9, F09VHB, F09VWL, F09VWM, F09VWN, F09VWP, F09VWQ, F09XY4, F09XY5, F09XY6, F09XY7, F09XY8, F09XYB, F09XYD, F09XYF, F09XYG, F09XYH, F09YQ7, F09YQ8, F09YQ9, F09YQB, F0B16J, F0B16K, F0B16M, F0B16P, F0B1K5, F0B1K6, F0B1K7, F0B1K8, F0B1K9, F0B5KP, F0B5KQ, F0B5KR, F0B5KT, F0B5KV, F0B5KW, F0B6K9, F0B6KB, F0B6KC, F0B6KD, F0B6KF, F0B6KG, F0B7ND, F0B7NF, F0B7NG, F0B7NH, F0B7NJ, F0B7NK, F0B7NM, F0B7NN, F0B7NQ, F0B7NT, F0B7NX, F0B7NY, F0B7P0, F0B7P4, F0B7P5, F0B7X9, F0B7XC, F0B7XD, F0B7XG, F0B8G7, F0B8G8, F0B8G9, F0B8GB, F0B95D, F0B95G, F0BB01, F0BB02, F0BB03, F0BBGT, F0BBGX, F0BBGY, F0BBGZ, F0BCFQ, F0BCFR, F0BDMQ, F0BDMR, F0BDMT, F0BDMV, F0BFK8, F0BFKB, F0BFKC, F0BFXH, F0BFXJ, F0BFXK, F0BFXM, F0BFXN, F0BFXQ, F0BFXV, F0BHWP, F0BHWQ, F0BHWR, F0BHWT, F0BHWV, F0BHWW, F0BHZP, F0BHZR, F0BHZT, F0BHZV, F0BHZW, F0BHZZ, F0BJ00, F0BJ01, F0BJ9X, F0BJ9Y, F0BJB0, F0BJB1, F0BJB2, F0BJYQ, F0BJYR, F0BL03, F0BL06, F0BMC1, F0BMC4, F0BMC5, F0BMC6, F0BN4N, F0BN4T, F0BN4V, F0BR78, F0BR79, F0BR7B, F0BR7D, F0BRMH, F0BRMJ, F0BT87, F0BT88, F0BT8B, F0BT8C, F0BVPB, F0BVPC, F0BVPF, F0BW00, F0BW01, F0BW02, F0BW03, F0BW04, F0BW05, F0BXCT, F0BXCV, F0BXCW, F0BXCX, F0BXCY, F0BXT4, F0BXT5, F0BXT7, F0C3W1, F0C4DJ, B3TBRW, F01W12, F01ZG6, F01ZZ5, F024G2, F03Q35, F04DX8, F04DXC, F04DXD, F04F28, F04F29, F04F2G, F04F2H, F04F2L, F07GY0, F07XRT, F07XRV, F07XRX, F07Y4Q, F09NLQ, F09NLR, F0B95H, F0BBGW, B3PZBK, F03561, F03JJ7, F054CP, F08Y2Z, F05VJ4, F07QBQ, F021MP, F02WLR, F01GWF, B2ZHFB, B3PYF8, F00MC6, F01QCD, F03Z3Q, F05Q7Q, F09BTL, B2ZHX2, F04655, B3HX01, F09N4L, F026YN, F05Y8M, F045L3, B2ZVMB, F09BTM, F0BCFM, F0BB04, F0BFK9, F097QP, F061X4, F09F4B, F03K58, F08ZR1, F011M1, F01MPH, F02MX4, F01QCL, F06TCC, B35BYY, F09F3W, F0295R, F05DHN, F00XH9, F09XYC, B3Q08H, B1MKLW, B3HMKL, F009V6, F045L6, F06WH0, B3L4N2, F04F24, F01MV2, F0BT89, F0BVP9, B3FT4V, F04F26, F09F47, B3FH7X, F05J7K, F09JT4, B0WH4P, B3HY5P, B35JQ4, B3HLN6, F05PR5, F09MHD, F00Q08, F027TG, F049Y9, F09YQ6, F00MCQ, F00Z9K, F04Y32, F09F44, F0152T, F03LBN, B32MKY, B2JFNX, B3Q5WZ, B3L5BB, F0568H, B3FTPN, F00NQB, B2RVM9, B3LFRX, F009V5, B3LFT2, B3TCCV, F03MCP, B3L4FD, B1YQC1, F081WX, F05PR8, B3L4LZ, F033JD, F0B16N, B3LFJF, F02Y1L, F0BR7F, F0723Y, B2867Q, B3HX2C, F0152P, F07D6G, B3L4QJ, B2ZHB2, F009V0, B18NV8, F04444, B23M55, B3HWZT, B2ZR05, B32MK3, F02RND, F09C1J, F0B7NZ, F0B7P1, F0B7P3, F0BJ02, F0BL05, F0BL07, B25331, B3LDH7, F0603X, F097QR, F097QT, F09BTF, F09BTJ, F09BTK, F09C1K, F09F46, F09JT1, F09VH8, F0B7NL, F0B7NP, F0B7NR, F0B7NW, F0B7P2, F0B9ZZ, F0BB00, F0BBGV, F0BCFL, F0BCFN, F0BCFP, F0BDMW, F0BDMX, F0BFKD, F0BFXL, F0BFXP, F0BFXT, F0BFXW, F0BHZQ, F0BHZY, F0BJ9Z, F0BJYV, F0BMC3, B0T4K4, B2JDYH, B2PWBT, B2RL1T, B35JLT, B3TCYD, F01X0Z, F04TQ8, F05QVR, F06WH6, F07D6C, F09V2B, F0B7XB, F0B7XF, F0B8G6, F0B95B, F0B95C, F0BFK7
Distribution pattern: Worldwide - US Nationwide distribution including in the states of FL, MN, AZ, NC, CA, MO, OH, WV, AL, NH, IN, IL, VT, PA, NY, NE, TX, WI, MI, KY, NV, MA, SD, LA, CO, TN, AK, GA, WA, UT, NM, ME, AR, SC and the countries of Italy, China, Netherlands, New Zealand, Hungary, Australia, France, Thailand, C¿te D'Ivoire, Germany, Canada, Mexico, Spain, Saudi Arabia, Uzbekistan, Greece, Yemen.
Derived failure modes
-
Unknown
Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, and electric shock if the built-in safety measures to prevent electric were to also fail.