Welch Allyn, Inc. 901060 (REF 68NXTX-B)Recalls & reported problems
Welch Allyn, Inc. · Welch Allyn Connex 6800 Vital Signs Monitor with 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
2 open recalls name 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
- 2
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00732094150810), received between Jul 12, 2023 and Jan 6, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fire” (1 report).
2 FDA recall records name this device's identifier, 2 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 ↗
- Mar 21, 2025Class IIOpen, Classified
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Z-1564-2025 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Fire1
- Sparking1
Patient problems
- Burn(s)1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2025Fire; Fire
CUSTOMER REPORTED CVSM DEVICE CAUGHT FIRE. THIS INCIDENT WAS CAPTURED UNDER HILLROM REF #(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21077916 ↗MalfunctionJul 12, 2023Sparking; Sparking
THE CUSTOMER REPORTED THE VITAL SIGNS MONITOR POWER CORD SPARKED AND BURNED. THE USER PULLED THE POWER CORD OUT OF THE WALL AND BURNED THEIR HANDS. NO MEDICAL INTERVENTION WAS REPORTED AT THE TIME OF THE INITIAL REPORT. MULTIPLE FOLLOW UP ATTEMPTS WERE PERFORMED, BUT NO ADDITIONAL INFORMATION WAS OBTAINED FROM THE CUSTOMER. THIS INCIDENT WAS CAPTURED UNDER HILLROM REF # (B)(4).
Patient problems: Burn(s)
MAUDE report 17304386 ↗
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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
- 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
- Change Healthcare Cardiology Hemo 14.1.1Change Healthcare Israel Ltd · 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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