Transducer eL18-4 989605456291Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884838070813), received between Mar 14, 2019 and Mar 29, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (2 reports).

4 FDA recall records name this device's identifier, 4 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jul 3, 2025Class IIIOpen, Classified

   To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

   Z-2404-2025 · Root cause: Device Design · Recall details · FDA record ↗

2. Jul 3, 2025Class IIIOpen, Classified

   To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

   Z-2369-2025 · Root cause: Device Design · Recall details · FDA record ↗

3. Jul 3, 2025Class IIIOpen, Classified

   To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

   Z-2372-2025 · Root cause: Device Design · Recall details · FDA record ↗

4. May 28, 2025Class IIOpen, Classified

   Ultrasound transducer devices were refurbished beyond their useful life.

   Z-2052-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2019Poor Quality Image

  IT WAS REPORTED THAT DUE TO AN IMAGE QUALITY ISSUE WITH AN EL-18-4 TRANSDUCER MODEL DURING A MAMMOGRAM, A PATIENT NEEDED TO BE RESCANNED WITH A DIFFERENT TRANSDUCER TO ENSURE A PROPER DIAGNOSIS. UPON RESCANNING THE PATIENT, THE CUSTOMER IDENTIFIED THE NEED FOR A BREAST BIOPSY. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8466385 ↗
• MalfunctionMar 14, 2019Poor Quality Image

  A CUSTOMER REPORTED AN IMAGE QUALITY ISSUE WITH AN EL-18-4 MODEL TRANSDUCER DURING A BREAST BIOPSY. THE CUSTOMER WAS UNABLE TO IDENTIFY THE BREAST LESION DUE TO THE POOR IMAGE QUALITY PRODUCED BY THE TRANSDUCER. THE CUSTOMER USED ANOTHER TRANSDUCER TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8422469 ↗