FDA Device Recall Z-0027-2014: SonoSite, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0027-2014.

Recall Res Number

Z-0027-2014

Recalling Firm / Manufacturer

SonoSite, Inc.

FEI Number

3002087856

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2013-09-11

Date Posted

2013-10-18

Date Terminated

2013-12-11

Product Code

IYO

Event Number

66346

Product Quantity

10 units

Product Description 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.

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

Action Details 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.

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.

Code Information / Serial Numbers Serial Number: 03T861; 03T863; 03T865; 03T867; 03T869; 03T85Z; 03T86C; 03T86F; 03T86H; 03T86K.

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Medical Device Recall: Z-0027-2014

Recall Parameters & Description

Related Establishments / Registrations

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