Welch Allyn, Inc. 901128 (REF CC-RXX-WADX)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, DICOM · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00817655022598), received between Aug 27, 2021 and May 7, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Patient Data Problem” (4 reports).
1 FDA recall record name this device's identifier, 1 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.
Reports received per month
Recalls naming this device
- Oct 11, 2024Class IIOpen, Classified
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
Z-0324-2025 · Root cause: Software design · Recall details · FDA record ↗
Most reported problems
Device problems
- Patient Data Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2026Patient Data Problem
BAXTER RECEIVED A REPORT STATING THAT CONNEX CARDIO PC SOFTWARE WAS POPULATING INCORRECT PATIENT ID FOR PATIENTS. CUSTOMER NOTED THIS HAPPENING WITH PATIENTS WITH MIDDLE INITIALS IN THEIR DEMOGRAPHICS. THE EVENT OCCURRED AFTER PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25119459 ↗MalfunctionSep 26, 2023Patient Data Problem; Patient Data Problem
THE CUSTOMER REPORTED TWO STUDIES FROM TWO DIFFERENT FACILITIES SENT TO THE SAME PAC SYSTEM. THERE WAS NO PATIENT INJURY REPORTED. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4)..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17816284 ↗MalfunctionAug 24, 2023Patient Data Problem; Patient Data Problem
THE CUSTOMER REPORTED THAT THEY TOOK TWO EXAMS AT THE SAME TIME, AND WHEN THEY TRANSMITTED THEM, ONLY ONE WENT THROUGH WITH THE READINGS FROM THE OTHER. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF #:(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17612111 ↗MalfunctionAug 27, 2021Patient Data Problem; Patient Data Problem
HILLROM RECEIVED A REPORT FROM THE CUSTOMER STATING IT WAS REPORTED THAT THE ECG WAVEFORM FOLLOWING TRANSMISSION DID NOT MATCH THE PATIENT IDENTIFICATION. THE ECG DEVICES WERE LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12377497 ↗
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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 · each recall links to the FDA recall notice
- 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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