Welch Allyn, Inc. 901001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00732094210613), received between May 13, 2021 and Sep 25, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Sparking” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K142356); they may or may not involve this specific model.

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

1. Mar 24, 2025Class IIOpen, Classified

   There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.

   Z-1559-2025 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Melted; Failure to Power Up; Sparking; Electrical Overstress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902927 ↗
• MalfunctionSep 24, 2026Thermal Decomposition of Device; Sparking

  Baxter received a report stating that a Power Management Stand emitted sparks and burning smell. The power cable appeared to be blackened. The process step during which this occurred was unknown. There was no patient/user injury, medical intervention, symptom, or adverse event reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877612 ↗
• MalfunctionFeb 4, 2025Overheating of Device; Overheating of Device

  CUSTOMER REPORTED THAT A STRONG SMELL OF BURNING WAS COMING FROM THE ACCESSORY POWER MANAGEMENT (APM). THE APM WAS UNSCREWED AND IT WAS FOUND THAT AN INTERNAL COMPONENT HAS BURNED ON THE POWER SUPPLY BOARD. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21302445 ↗
• MalfunctionJun 18, 2024Fire; Fire

  IT WAS REPORTED THAT THE CONNEX SPOT MONITOR WAS PLUGGED IN WHEN STAFF HEARD A POP. STAFF THEN NOTED SMOKE AND FIRE COMING FROM THE DEVICE. THERE WAS NO REPORT OF SERIOUS INJURY. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19555810 ↗
• MalfunctionMay 13, 2021Electrical Power Problem; Electrical Power Problem

  THE CUSTOMER REPORTED THAT THE POWER CORD ATTACHED TO THE APM EXPLODED WHILE THE DEVICE WAS IN USE. THE CUSTOMER ALSO STATED THAT BOTH THE APM AND THE CSM ARE FUNCTIONING AS DESIGNED. THERE WAS NO REPORT OF SERIOUS INJURY. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11819202 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142356. One submission often covers many models, so check the product and lot details in each record.

• Z-1564-2025 · Mar 21, 2025 · Open, Classified
  Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Product Code/Part # 67MXTX-B; 3) ) Product Code/Part # 67MXXP-B
• Z-1565-2025 · Mar 21, 2025 · Open, Classified
  Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6; 5) 44WT-B; 6) 44XT-2; 7) 44XT-4; 8) 44XT-6; 9) 44XT-B.
• Z-2581-2023 · Aug 10, 2023 · Open, Classified
  Welch Allyn Connex Spot Monitor