Welch Allyn, Inc. 901128 (REF DCSS-CXX)Recalls & reported problems
Welch Allyn, Inc. · Welch Allyn Diagnostic Cardiology Suite Spirometry; Software, Spirometer, USB cable, pressure tubing, handle, 4 pack of flow transducers, Calibration Syringe · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00732094325386), received between May 21, 2026 and May 21, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Patient Data Problem” (1 report).
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 Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2026Patient Data Problem
A CUSTOMER CONTACTED TECHNICAL SERVICE TO REPORT THAT THE DIAGNOSTIC CARDIOLOGY SUITE HAD INCORRECT PATIENT INFORMATION PULLED IN WHEN TAKING EXAM THROUGH VERADIGM/ALLSCRIPTS. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25250016 ↗
Other SPIROMETER, DIAGNOSTIC devices
- Vmax 773835-101Carefusion Corporation · Spirometer, Diagnostic2 reports
- Vyaire 36-ML3500 MK8-STKJaeger Medical GmbH · Spirometer, Diagnostic1 report
- Welch Allyn, Inc. 901047Welch Allyn, Inc. · SPIROMETER, DIAGNOSTIC1 report
- Vmax 773835-103Carefusion Corporation · Spirometer, Diagnostic1 report
- Vyaire 36-ML3535 MK8-STKJaeger Medical GmbH · Spirometer, Diagnostic1 report
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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