—#202483

Product

3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000

FDA product code: ITX — Transducer, Ultrasonic, Diagnostic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K042540, K043535, K081661, K120321, K132304, K222648
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

On 6/30/23, recall notices were sent to customers who were advised to do the following: 1) Stop usage and/or distribution of affected transducers and secure them in a location where they cannot inadvertently be used. 2) Circulate the notice to all users of this device so that they are aware of the issue. Retain this notice with your system(s) and ensure the letter is in a place likely to be seen/viewed. 3) Complete and return the response form via email to: ultrasound.corrections@philips.com Field Service Engineers will visit your site to provide a replacement device, and collect the affected product. Contact Customer Care Solutions Center if you need further information or support concerning this issue at 1-800-722-9377. On 7/24/23 additional recall notices were distributed to customers informing them that additional devices were found to be affected.

Recalling firm

Firm: Philips Ultrasound, Inc.
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

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.

Timeline

Recall initiated: 2023-06-30
Posted by FDA: 2023-09-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #202483. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.