🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: September 11, 2013 SonoSite Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial Number: 03T861; 03T863; 03T865; 03T867; 03T869; 03T85Z; 03T86C; 03T86F; 03T86H; 03T86K.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
SonoSite, Inc.
Reason for Recall:
FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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 Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0027-2014