Welch Allyn, Inc. 901143 (REF 11110-003-50)Recalls & reported problems
Welch Allyn, Inc. · SOFTWARE HSCRIBE v6.2.0 · 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 00732094281330), received between Feb 13, 2026 and Jul 30, 2026 — 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.
MalfunctionJul 30, 2026Patient Data Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50090433 ↗MalfunctionFeb 13, 2026Patient Data Problem
THE CUSTOMER REPORTED THAT THEY HAD A PATIENT APPEARING TWICE IN HSCRIBE WITH EXACTLY THE SAME NAME, NHS NUMBER, DATE OF BIRTH, AND SETUP TIMESTAMP (SAME DAY, HOUR, MINUTE, AND SECOND). HOWEVER, WHEN OPENING EACH RECORD, THE ECG TRACES WERE COMPLETELY DIFFERENT AND CLEARLY CORRESPOND TO TWO DIFFERENT PATIENTS. THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24338651 ↗
Other ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM devices
- HScribe HSERV-6AA-XXXXBMortara Instrument, Inc. · Electrocardiograph, Ambulatory, With Analysis Algorithm1 recall1 report
- Welch Allyn, Inc. 901143Welch Allyn, Inc. · ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM1 recall0 reports
- Welch Allyn, Inc. 901143Welch Allyn, Inc. · ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM1 recall0 reports
- Welch Allyn, Inc. 901143Welch Allyn, Inc. · ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM1 recall0 reports
- Welch Allyn, Inc. 901143Welch Allyn, Inc. · ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM1 recall0 reports
- Welch Allyn, Inc. 901143Welch Allyn, Inc. · ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM1 recall0 reports
- Welch Allyn, Inc. 901143Welch Allyn, Inc. · ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM1 recall0 reports
- HScribe HSCRIBE-6AA-AXXXBMortara Instrument, Inc. · Electrocardiograph, Ambulatory, With Analysis Algorithm1 recall0 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page