Welch Allyn, Inc. 901057 (REF 44WT)Recalls & reported problems
Welch Allyn, Inc. · Spot 4400 with NIBP SureTemp and Nonin · 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00732094309232), received between Dec 23, 2020 and Oct 4, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fire” (1 report).
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.
Recalls naming this device
- Mar 21, 2025Class IIOpen, Classified
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Z-1565-2025 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Fire1
- Overheating of Device1
Patient problems
- Electric Shock1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 4, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT A NURSE RECEIVED AN ELECTRICAL SHOCK WHEN DISCONNECTING THE POWER CABLE OF A SPOT 4400 FROM THE WALL OUTLET. THIS EVENT WAS CAPTURED UNDER HILL-ROM COMPLAINT REF # (B)(4).
Patient problems: Electric Shock
MAUDE report 15535209 ↗MalfunctionDec 23, 2020Fire; Fire
WELCH ALLYN RECEIVED A REPORT FROM THE ACCOUNT STATING THE SPOT VS DEVICE POWER SUPPLY CAUGHT FIRE. THE DEVICE WAS 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 Patient Involvement
MAUDE report 11064611 ↗
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- Change Healthcare Cardiology Hemo 14.2Change Healthcare Canada Company · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2 recalls1 death1 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 · 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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