Events

Recall of P21x/51 MHz transducer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by SonoSite, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66346
  • Event Risk Class
    Class 2
  • Event Number
    Z-0027-2014
  • Event Initiated Date
    2013-09-11
  • Event Date Posted
    2013-10-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122088
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, imaging, pulsed echo, ultrasonic - Product Code IYO
  • Reason
    Fujifilm sonosite inc. remove p21x/5-1 transducer because the firm discovered the biopsy bracket sensor is not working as intended.
  • 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.

Device

P21x/51 MHz transducer
  • Model / Serial
    Serial Number: 03T861; 03T863; 03T865; 03T867; 03T869; 03T85Z; 03T86C; 03T86F; 03T86H; 03T86K.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide in the states of Florida, Georgia, Oklahoma, Pennsylvania, Tennessee, Texas, West Virginia, and in the country Japan and Italy.
  • 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.
  • Manufacturer
    SonoSite, Inc.

Manufacturer

SonoSite, Inc.
  • Manufacturer Address
    SonoSite, Inc., 21919 30th Dr SE, Bothell WA 98021-3904
  • Manufacturer Parent Company (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA