Welch Allyn, Inc. 901057 (REF 420TB-E1)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00732094006469), received between Dec 2, 2020 and Dec 2, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fire” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K101680); 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2020Fire; Fire

  WELCH ALLYN RECEIVED A REPORT FROM THE ACCOUNT STATING THE SPOT VS DEVICE POWER SUPPLY CAUGHT FIRE WHILE THE DEVICE WAS PLUGGED INTO THE WALL OUTLET. 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 10934597 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101680. One submission often covers many models, so check the product and lot details in each record.

• Z-1509-2024 · Mar 26, 2024 · Open, Classified
  Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,EU, Product Code 34BFST-2; b)
• Z-1673-2021 · Apr 22, 2021 · Terminated
  ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models) Model: 34XFHT-B Intended: ProBP 3400 automatically measures systolic and diastolic pressur