Transducer X7-2t 989605361911Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884838023987), received between Dec 3, 2019 and Dec 8, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (1 report).

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-2412-2025 · Root cause: Device Design · Recall details · FDA record ↗

2. May 28, 2025Class IIOpen, Classified

   Ultrasound transducer devices were refurbished beyond their useful life.

   Z-2066-2025 · 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.

• MalfunctionDec 8, 2020Mechanical Jam; Mechanical Jam

  A CUSTOMER REPORTED AN X7-2T MODEL TRANSDUCER EXPERIENCED AN ARTICULATION ISSUE DURING USE. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10971221 ↗
• MalfunctionDec 3, 2019Therapeutic or Diagnostic Output Failure

  A CUSTOMER REPORTED THEIR X7-2T MODEL TRANSDUCER WAS NOT FULLY ADJUSTING THE ARTICULATION ANGLE. THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9405817 ↗