Welch Allyn, Inc. 901058 (REF 75ME-B)Recalls & reported problems
Welch Allyn, Inc. · Welch Allyn Connex Spot Monitor with SureBP Non-invasive Blood Pressure, Masimo SpO2, Braun ThermoScan PRO 6000 Thermometer · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00732094209419), received between Oct 8, 2020 and Oct 8, 2020 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Mar 21, 2025Open, Classified
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Z-1563-2025 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Fire1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2020Fire
WELCH ALLYN RECEIVED A REPORT FROM THE ACCOUNT STATING THE CSM DEVICE CAUGHT FIRE WHILE THE DEVICE WAS CHARGING AND NOT IN USE. 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 10651199 ↗
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- McKesson Cardiology Hemo 14.0Change Healthcare Canada Company · Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)2 recalls2 deaths2 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.