3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU2
Summary
The FDA issued a Class II for 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti by Philips Ultrasound, Inc.. 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.
Details
Source
Device Recall
External ID
Z-2517-2023
Action Date
2023-09-13
Status
Completed
Category
device
Product Description
3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
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
Quantity Affected: 449
Reason for Recall
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.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-30
Company
Bothell, WA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 148 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips Ultrasound, Inc. has 111 FDA actions in our database, including 111 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips Ultrasound, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips Ultrasound, Inc. have FDA actions?
Philips Ultrasound, Inc. has 111 FDA actions in our database, including 111 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2517-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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