SonoSite, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0027-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 11, 2013

Date Posted: October 23, 2013

Recall Number: Z-0027-2014

Event ID: 66346

Reason for Recall:

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

Status: Terminated

Product Quantity: 10 units

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated