Recall Z-0027-2014 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
SonoSite, Inc.
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
| Date | Oct 18, 2013 (initiated Sep 11, 2013) |
| Status | Terminated |
| Reason | FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |