Transducer S8-3t 989605420183Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00884838067523), received between Mar 20, 2018 and Feb 5, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (8 reports).

2 FDA recall records name this device's identifier, 2 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-2398-2025 · Root cause: Device Design · Recall details · FDA record ↗

2. May 28, 2025Class IIOpen, Classified

   Ultrasound transducer devices were refurbished beyond their useful life.

   Z-2061-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2021Mechanical Jam; Mechanical Jam

  A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER HAD AN ARTICULATION ISSUE DURING USE. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11285673 ↗
• MalfunctionAug 11, 2020Poor Quality Image

  A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS PRODUCING POOR IMAGE QUALITY. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10390790 ↗
• MalfunctionAug 7, 2020Poor Quality Image

  A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER HAD AN IMAGE QUALITY ISSUE. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10379969 ↗
• MalfunctionJun 29, 2020Poor Quality Image

  A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS PRODUCING POOR IMAGE QUALITY. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10207188 ↗
• MalfunctionJan 10, 2020Poor Quality Image

  A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS PRODUCING POOR IMAGE QUALITY. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9575963 ↗
• MalfunctionDec 31, 2019Poor Quality Image

  A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS PRODUCING POOR IMAGE QUALITY. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9535223 ↗
• MalfunctionAug 13, 2019Poor Quality Image

  A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS PRODUCING DETERIORATED 2D IMAGE QUALITY. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8889332 ↗
• MalfunctionJun 3, 2019Image Display Error/Artifact

  A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS PRODUCING IMAGE ARTIFACTS IN COLOR MODE. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8663596 ↗
• MalfunctionFeb 28, 2019Poor Quality Image

  A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS PRODUCING POOR IMAGE QUALITY. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8378542 ↗
• MalfunctionMar 20, 2018Poor Quality Image

  A CUSTOMER REPORTED AN S8-3T MODEL TRANSDUCER WAS PRODUCING BLURRY IMAGES. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7353116 ↗