Reported Sep 13, 2023 · Completed

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

Philips Ultrasound, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Ultrasound, Inc. · 22100 Bothell Everett Hwy · Bothell, WA · 98021-8431

Is this the product you have?

  • 3D9-3v Transducer
  • accessory to Philips Ultrasound Systems
    • EPIQ Elite
    • Affiniti 30
    • 50
    • and 70
    • ClearVue 850
    • HD15
    • iU22
    • and Compact 5000
Lot codes and dates
  • UDI-DI00884838061545
  • Serial Numbers

    449 of 449 codes

    • 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
Amount recalled
449

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.