Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

P21x/5-1 MHz transducer Recalled by SonoSite, Inc. Due to FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the...

Date: September 11, 2013
Company: SonoSite, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact SonoSite, Inc. directly.

Affected Products

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.

Quantity: 10 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About SonoSite, Inc.

SonoSite, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report