Welch Allyn, Inc. 901060 (REF 65NTXX-B)Recalls & reported problems
Welch Allyn, Inc. · Welch Allyn Connex 6500 Electronic Vitals Documentation System; Nellcor SpO2, SureTemp Plus Thermometry, SureBP Non-invasive Blood Pressure, Pulse Rate, MAP, BP Averaging, Nurse Call, Four USB Ports for Accessories, Internal 802.11 a/b/g Wireless Radio; 100-240 V, 50-60 Hz AC, IEC Plug Type-B · 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00732094088151), received between Jul 14, 2021 and Nov 4, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fire” (3 reports).
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.
Reports received per month
Recalls naming this device
- 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-1558-2025 · Root cause: Process design · Recall details · FDA record ↗
Most reported problems
Device problems
- Fire3
- Sparking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Electric Shock1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2025Fire; Fire
CUSTOMER REPORTED THAT THE CVSM DEVICE CAUGHT FIRE. IT WAS ADDITIONALLY STATED THAT STAFF WAS ABLE TO UNPLUG THE DEVICE FROM AC POWER AND PUT THE FIRE WITH A FIRE EXTINGUISHER. THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23462513 ↗MalfunctionJul 9, 2025Fire; Sparking; Fire; Sparking
IT WAS REPORTED THAT WHEN A CAREGIVER ATTEMPTED TO USE THE VSM 6500 VITAL SIGNS MONITORING DEVICE, THE DEVICE STARTED SPARKING, THE CAREGIVER FELT AN ELECTRIC SHOCK UP THE ARM, AND THE DEVICE WAS THEN ENGULFED IN FLAMES. THE CAREGIVER WAS EVALUATED IN THE EMERGENCY ROOM. THE CUSTOMER REPORTED THAT NO SIGNIFICANT INJURY OCCURRED. ANY TREATMENT PROVIDED TO THE CAREGIVER WHILE UNDER OBSERVATION IN THE ER IS UNKNOWN.
Patient problems: Electric Shock
MAUDE report 22456553 ↗MalfunctionJul 14, 2021Fire; Fire
WELCH ALLYN RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THE CVSM 6500 CAUGHT ON 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 Clinical Signs, Symptoms or Conditions
MAUDE report 12169698 ↗
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- Welch Allyn, Inc. 901058Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls5 reports
- Welch Allyn, Inc. 901060Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls3 reports
- Welch Allyn, Inc. 901060Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls2 reports
- McKesson Cardiology Hemo 14.0Change Healthcare Canada Company · Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)2 recalls2 deaths2 reports
- 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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