Transducer L12-3 989605412072Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838061620), received between Mar 10, 2020 and Mar 10, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “No Display/Image” (1 report).

5 FDA recall records name this device's identifier, 5 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-2389-2025 · 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-2372-2025 · 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-2376-2025 · Root cause: Device Design · Recall details · FDA record ↗

4. Jul 3, 2025Class IIIOpen, Classified

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

   Z-2352-2025 · Root cause: Device Design · Recall details · FDA record ↗

5. May 28, 2025Class IIOpen, Classified

   Ultrasound transducer devices were refurbished beyond their useful life.

   Z-2054-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2020No Display/Image

  A CUSTOMER REPORTED AN L12-3 MODEL TRANSDUCER HAD A PARTIAL IMAGE DROPOUT THAT CAUSED AN EXTENDED PROCEDURE DELAY. THE DELAY REQUIRED ADMINISTERING AN ADDITIONAL DOSE OF ANESTHESIA TO THE PATIENT WHILE A SECONDARY ULTRASOUND SYSTEM WAS BEING ACQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT ULTRASOUND SYSTEM AVAILABLE AT THE CUSTOMER SITE. THERE WAS NO INJURY OR ADVERSE PATIENT OUTCOME ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9813614 ↗