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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92761

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 30, 2023
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
Philips Ultrasound, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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
Recall number
Z-2517-2023
Initiated
June 30, 2023
Classification
Class II
Status
Completed
Recalling firm
Philips Ultrasound, Inc.
Quantity
449

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

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.