Welch Allyn, Inc. 901128 (REF CC-RXX-WAXX)Recalls & reported problems
Welch Allyn, Inc. · Connex Cardio PC based 12-Lead Multi-Channel Resting ECG - software, Connex Cardio WAM wireless acquisition module, AHA 10 wire, 12-lead lead set with banana plugs, CardioSens Ultra II resting tab electrodes (pouch of 100), Clear Choice adapter clips (set of 10), Connex Cardio UTK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817655022604), received between Dec 15, 2023 and Aug 11, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Patient Data Problem” (2 reports).
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
- Patient Data Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2025Patient Data Problem; Patient Data Problem
THE CUSTOMER REPORTED INCORRECT PATIENT INFORMATION WITH THE CORRECT PATIENT ID WAS PULLING FROM THE EMR. THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22769060 ↗MalfunctionDec 15, 2023Patient Data Problem; Patient Data Problem
THE CUSTOMER REPORTED A NUMBER OF CONFIGURATION ISSUES WITH THE WADCS INCLUDING THE PATIENT ID WAS INCORRECT. THERE WAS NO ASSOCIATED ADVERSE EVENT REPORTED AS A RESULT OF THIS INCIDENT.THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18334318 ↗
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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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