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.
FDA Recall Z-0027-2014 · Posted 2013-10-18
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Recalling FirmSonoSite, Inc.
Recall StatusTerminated
Product CodeIYO
Date Initiated2013-09-11
Date Terminated2013-12-11
Product Quantity10 units
Reason for Recall
FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended.
Firm Action
SonoSite started calling their consignees on September 13, 2013. For customers who could not be reached via phone, a letter Urgent -Medical Device Removal will be sent on September 17, 2013. Affected customers will be offered a replacement transducer (P07698-24) free of charge. Consignees in the U.S. can call 1-877-657-8118, Monday-Friday, 6:00 a.m. - 5:00 p.m. (PST) or send E-mail to [email protected]. Customers outside the US can call 425-951-1200.
Root Cause
Error in labeling
Distribution Pattern
Worldwide Distribution - USA Nationwide in the states of Florida, Georgia, Oklahoma, Pennsylvania, Tennessee, Texas, West Virginia, and in the country Japan and Italy.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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