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SonoSite, Inc. recalls P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed f
Recalled October 23, 2013 · FDA recall Z-0027-2014 · SonoSite
Hazard
FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended. · FDA Class II
Units
10 units
Sold at
Worldwide Distribution - USA Nationwide in the states of Florida, Georgia, Oklahoma, Pennsylvania, Tennessee, Texas, West Virginia, and in the country Japan and Italy.
Description
FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended.
Product
P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The 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.
Manufacturer(s)
SonoSite, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →