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U.S. Department of Health and Human Services

Class 2 Device Recall P21x/51 MHz transducer

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 Class 2 Recall
P21x/51 MHz transducer
see related information
Date Posted October 18, 2013
Recall Status1 Terminated on December 11, 2013
Recall Number Z-0027-2014
Recall Event ID 66346
Premarket Notification
510(K) Numbers
K113156  K130173 
Product Classification System, Imaging, Pulsed Echo, Ultrasonic - Product Code IYO
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.
Code Information Serial Number: 03T861; 03T863; 03T865; 03T867; 03T869; 03T85Z; 03T86C; 03T86F; 03T86H; 03T86K.
Recalling Firm/
Manufacturer
SonoSite, Inc.
21919 30th Dr SE
Bothell, Washington 98021-3904
Manufacturer Reason
for Recall
FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
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 service@sonosite.com. Customers outside the US can call 425-951-1200.
Quantity in Commerce 10 units
Distribution Worldwide Distribution - USA Nationwide in the states of Florida, Georgia, Oklahoma, Pennsylvania, Tennessee, Texas, West Virginia, and in the country Japan and Italy.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYO and Original Applicant = FUJIFILM SONOSITE,INC.
510(K)s with Product Code = IYO and Original Applicant = SONOSITE,INC.
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