Z-2517-2023Class II

3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue...

Name: Z-2517-2023 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue...
Creator: Philips Ultrasound, Inc.
Published: 2023-06-30
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2023-06-30 / Completed / root cause: manufacturing process

FDA source

Philips Ultrasound, Inc. began a recall of 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000 on 2023-06-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2517-2023
Classification: Class II
Status: Completed
Initiated: 2023-06-30
Posted: 2023-09-06
Recalling firm: Philips North America LLC
Product: 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
Product code: ITX Transducer, Ultrasonic, Diagnostic
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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: [email protected] 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.
Quantity in commerce: 449
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2517-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2517-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-13	2023-09-06

Product code ITX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)