FDA Device recall Z-2517-2023
3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite
- FDA Device
- Class II
- completed
- Published 2023-09-13
On 2023-09-13 the FDA classified a Class II recall of 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite by Philips Ultrasound, citing 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 patie….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2517-2023 |
| Classification | Class II |
| Status | completed |
| Initiated | 2023-06-30 |
| Published | 2023-09-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Ultrasound |
| Distribution | US |
Product
3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
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.
Identifiers
| code_info | UDI-DI:00884838061545, Serial Numbers: F07VBZ, F083JP, F086Z5, F088QC, F08JPF, F08K4H, F08VLP, F08VLY, F08W1C, F08W1D,…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, F |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2517-2023%22
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