Reported Oct 23, 2013 · Terminated

P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for…

SonoSite, 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: SonoSite, Inc. · 21919 30th Dr SE · Bothell, WA · 98021-3904

Is this the product you have?

  • P21x/5-1 MHz transducer
  • Part Number P07698-23 Product UsageThe P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler
Lot codes and dates
  • Serial Number
    • 03T861
    • 03T863
    • 03T865
    • 03T867
    • 03T869
    • 03T85Z
    • 03T86C
    • 03T86F
    • 03T86H
    • 03T86K
Amount recalled
10 units

Where it was sold

Why it was recalled

FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended.

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

Notice updated Dec 11, 2013 · Data as of Sep 19, 5:29 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.