Welch Allyn, Inc. 901047Recalls & reported problems
Welch Allyn, Inc. · ASSY DVD CPWS SOFTWARE 1.6.6 - D · 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 00732094301212), received between Apr 1, 2026 and Apr 1, 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.
MalfunctionApr 1, 2026Patient Data Problem
THE CUSTOMER REPORTED THAT INCORRECT REPORTS WERE AUTO ATTACHING TO THE WRONG PATIENT FILE. 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 24757348 ↗
Other SPIROMETER, DIAGNOSTIC devices
- Vmax 773835-101Carefusion Corporation · Spirometer, Diagnostic2 reports
- Vyaire 36-ML3500 MK8-STKJaeger Medical GmbH · Spirometer, Diagnostic1 report
- Welch Allyn, Inc. 901128Welch 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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