Z6Ms Transducer 10436113Recalls & reported problems
Siemens Medical Solutions USA, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04056869003634), received between Apr 2, 2025 and Feb 18, 2026 — classified as 3 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
- No Apparent Adverse Event1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2026Appropriate Device Problem Term/Code Not Available
ERROR MESSAGE DURING Z6M EXAM: US ACQUISTION HW_31.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24376640 ↗MalfunctionFeb 18, 2026Appropriate Device Problem Term/Code Not Available
THE CUSTOMER REPORTED THAT WHEN CONNECTING THE Z6MS PROBE, THE DEVICE DISPLAYS THE ERROR US ACQUISITION HW_31 AND THE SYSTEM REQUESTS THE REMOVAL OF THE PROBE. THE ISSUE IS THERMAL IN NATURE AND OCCURS EVERY TIME THE PROBE IS CONNECTED. WHEN CONNECTING V5M TEE PROBES, THE ERROR DOES NOT OCCUR.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24376637 ↗MalfunctionApr 2, 2025No Apparent Adverse Event; No Apparent Adverse Event
COPIED FROM (B)(4). CUSTOMER STATED THAT THE DISTAL TIP ON HIS Z6MS LOCKED ITSELF IN A DEFLECTED POSITION DURING A PROCEDURE. UNCLEAR HOW HE RECOVERED FROM THAT. WHEN CSE INSPECTED THE PROBE, ALL WAS WORKING WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21750834 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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