Welch Allyn, Inc. 901011 (REF SCNODE-AEB-DJBXX)Recalls & reported problems
Welch Allyn, Inc. · ITAL. 220V 4 SL 4 CONFIGURE for 4 S4 · 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 00732094262735), received between Apr 28, 2023 and Apr 28, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Intermittent Communication Failure” (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.
Most reported problems
Device problems
- Intermittent Communication Failure1
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 28, 2023Intermittent Communication Failure; Intermittent Communication Failure
THE CUSTOMER REPORTED THAT THE SURVEYOR CENTRAL HAS INTERMITTENT CONNECTIVITY ISSUES, AND IT ALARMS CONTINUOUSLY ONCE RESTARTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16830086 ↗
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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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